Which peptides are FDA-approved?
Of the 62 peptides tracked here, 47 hold at least one FDA-approved application, 5 were approved and later discontinued, and 15 have no FDA record at all.
47
FDA-approved
5
Approved, discontinued
15
Never approved
6
With generics pending
21
Orphan designations
29
Priority reviews
3475
FDA documents linked
Generics in the pipeline
A tentative approval means the FDA has judged a generic to meet its standards but cannot approve it for marketing yet, usually because patents or exclusivity on the brand have not expired. These 6 peptides have generics already cleared and waiting.
| Peptide | Pending | Applicants |
|---|---|---|
| Carfilzomib | 6 | MSN (2026), AMNEAL PHARMS NY (2026), HAINAN POLY PHARM. CO., LTD. (2025), EUGIA PHARMA (2022) |
| Bivalirudin | 2 | MYLAN LABS LTD (2017), PLIVA HRVATSKA DOO (2016) |
| Semaglutide | 1 | APOTEX INC (2026) |
| Degarelix | 1 | CHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD. (2025) |
| Vasopressin | 1 | AMNEAL EU LTD (2022) |
| Linaclotide | 1 | ACTAVIS LABS FL INC (2026) |
Every peptide, at a glance
| Peptide | FDA status | First approval | Brands |
|---|---|---|---|
| Abaloparatide | FDA-approved | 2017-04-28 | TYMLOS |
| Afamelanotide | FDA-approved | 2019-10-08 | SCENESSE |
| Bivalirudin | FDA-approved | 2000-12-15 | ANGIOMAX, ANGIOMAX RTU, BIVALIRUDIN |
| Bremelanotide | FDA-approved | 2019-06-21 | VYLEESI (AUTOINJECTOR) |
| Calcitonin | FDA-approved | 1978-04-17 | CALCIMAR, CALCITONIN-SALMON, CIBACALCIN |
| Carfilzomib | FDA-approved | 2012-07-20 | CARFILZOMIB, KITPROZY, KYPROLIS |
| Cetrorelix | FDA-approved | 2000-08-11 | CETRORELIX ACETATE, CETROTIDE |
| Corticorelin | FDA-approved | 1996-05-23 | ACTHREL |
| Cosyntropin | FDA-approved | 1970-04-22 | CORTROSYN, COSYNTROPIN |
| Degarelix | FDA-approved | 2008-12-24 | DEGARELIX ACETATE, FIRMAGON |
| Desmopressin | FDA-approved | 1978-02-21 | CONCENTRAID, DDAVP, DDAVP (NEEDS NO REFRIGERATION) |
| Dulaglutide | FDA-approved | 2014-09-18 | TRULICITY |
| Eptifibatide | FDA-approved | 1998-05-18 | EPTIFIBATIDE, INTEGRILIN |
| Exenatide | FDA-approved | 2005-04-28 | BYDUREON, BYDUREON BCISE, BYDUREON PEN |
| Ganirelix | FDA-approved | 1999-07-29 | FYREMADEL, GANIRELIX ACETATE |
| Glucagon | FDA-approved | 1960-11-14 | BAQSIMI, GLUCAGEN, GLUCAGON |
| Goserelin | FDA-approved | 1989-12-29 | ZOLADEX |
| Icatibant | FDA-approved | 2011-08-25 | FIRAZYR, ICATIBANT ACETATE |
| Insulin | FDA-approved | 1982-10-28 | ADMELOG, ADMELOG SOLOSTAR, AFREZZA |
| Lanreotide | FDA-approved | 2007-08-30 | LANREOTIDE ACETATE, SOMATULINE DEPOT |
| Leuprolide | FDA-approved | 1985-04-09 | CAMCEVI ETM, CAMCEVI KIT, ELIGARD KIT |
| Linaclotide | FDA-approved | 2012-08-30 | LINACLOTIDE, LINZESS |
| Liraglutide | FDA-approved | 2010-01-25 | LIRAGLUTIDE, SAXENDA, VICTOZA |
| Lixisenatide | FDA-approved | 2016-07-27 | ADLYXIN, SOLIQUA 100/33 |
| Octreotide | FDA-approved | 1988-10-21 | BYNFEZIA PEN, MYCAPSSA, OCTREOTIDE ACETATE |
| Oxytocin | FDA-approved | 1980-04-17 | OXYTOCIN, OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5% |
| Pasireotide | FDA-approved | 2012-12-14 | SIGNIFOR, SIGNIFOR LAR KIT |
| Plecanatide | FDA-approved | 2017-01-19 | TRULANCE |
| Romidepsin | FDA-approved | 2009-11-05 | ISTODAX, ROMIDEPSIN |
| Secretin | FDA-approved | 2002-04-04 | CHIRHOSTIM, PORCINE SECRETIN, SECREFLO |
| Semaglutide | FDA-approved | 2017-12-05 | OZEMPIC, RYBELSUS, SEMAGLUTIDE |
| Setmelanotide | FDA-approved | 2020-11-25 | IMCIVREE |
| Somatrogon | FDA-approved | 2023-06-27 | NGENLA |
| Somatropin | FDA-approved | 1986-10-16 | ACCRETROPIN, BIO-TROPIN, GENOTROPIN |
| Teduglutide | FDA-approved | 2012-12-21 | GATTEX KIT |
| Teriparatide | FDA-approved | 2002-11-26 | BONSITY, FORTEO, PARATHAR |
| Terlipressin | FDA-approved | 2022-09-14 | TERLIVAZ |
| Tesamorelin | FDA-approved | 2010-11-10 | EGRIFTA |
| Tirzepatide | FDA-approved | 2022-05-13 | MOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN |
| Triptorelin | FDA-approved | 2000-06-15 | TRELSTAR, TRIPTODUR KIT |
| Vasopressin | FDA-approved | 2014-04-17 | PITRESSIN TANNATE, VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5% |
| Ziconotide | FDA-approved | 2004-12-28 | PRIALT |
| Enfuvirtide | Approved, then discontinued | 2003-03-13 | FUZEON |
| Macimorelin | Approved, then discontinued | 2017-12-20 | MACRILEN |
| Nesiritide | Approved, then discontinued | 2001-08-10 | NATRECOR |
| Pramlintide | Approved, then discontinued | 2005-03-16 | SYMLIN |
| Sermorelin | Approved, then discontinued | 1990-12-28 | GEREF |
| Aod 9604 | Never FDA-approved | not applicable | none listed |
| Bpc 157 | Never FDA-approved | not applicable | none listed |
| Cjc 1295 | Never FDA-approved | not applicable | none listed |
| Epitalon | Never FDA-approved | not applicable | none listed |
| Ghrp 2 | Never FDA-approved | not applicable | none listed |
| Ghrp 6 | Never FDA-approved | not applicable | none listed |
| Hexarelin | Never FDA-approved | not applicable | none listed |
| Ipamorelin | Never FDA-approved | not applicable | none listed |
| Melanotan | Never FDA-approved | not applicable | none listed |
| Mots C | Never FDA-approved | not applicable | none listed |
| Selank | Never FDA-approved | not applicable | none listed |
| Semax | Never FDA-approved | not applicable | none listed |
| Ss 31 | Never FDA-approved | not applicable | none listed |
| Tb 500 | Never FDA-approved | not applicable | none listed |
| Thymosin Beta 4 | Never FDA-approved | not applicable | none listed |
FDA-approved peptide drugs (42)
Peptides with at least one original application the FDA has approved.
Abaloparatide
FDA-approvedReference listed drug
First approval2017-04-28
Brand namesTYMLOS
SponsorsRADIUS
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
Strengths3.12MG/1.56ML (2MG/ML)
FDA applicationsNDA208743
Label supplements10
RxCUI1921075
UNIIAVK0I6HY2U
Drug classParathyroid Hormone-Related Peptide Analog [EPC]
Afamelanotide
FDA-approvedReference listed drug Orphan designation Priority review
First approval2019-10-08
Brand namesSCENESSE
SponsorsCLIVUNEL INC
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsIMPLANT
Strengths16MG
FDA applicationsNDA210797
Label supplements1
RxCUI2262254
UNIIQW68W3J66U
Bivalirudin
FDA-approvedReference listed drug
First approval2000-12-15
Most recent approval2021-05-28
Brand namesANGIOMAX, ANGIOMAX RTU, BIVALIRUDIN, BIVALIRUDIN IN 0.9% SODIUM CHLORIDE
SponsorsACCORD HLTHCARE, APOTEX, BAXTER HLTHCARE CORP, DR REDDYS, EUGIA PHARMA
Marketing statusDiscontinued, None (Tentative Approval), Prescription
RoutesINJECTION, INTRAVENOUS
Dosage formsINJECTABLE, SOLUTION
Strengths250MG/50ML (5MG/ML), 250MG/VIAL, 500MG/100ML (5MG/ML)
Therapeutic equivalenceAP
FDA applicationsANDA090189, ANDA090811, ANDA090816, ANDA091206, ANDA091468, ANDA091602, ANDA201577, ANDA202471
Label supplements40
Pending generics2
RxCUI308769
UNIITN9BEX005G
Drug classAnti-coagulant [EPC]; Direct Thrombin Inhibitor [EPC]
Bremelanotide
FDA-approvedReference listed drug
First approval2019-06-21
Brand namesVYLEESI (AUTOINJECTOR)
SponsorsCOSETTE
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
StrengthsEQ 1.75MG BASE/0.3ML (EQ 1.75MG BASE/0.3 ML)
FDA applicationsNDA210557
Label supplements1
RxCUI2176316
UNIIPV2WI7495P
Calcitonin
FDA-approvedReference listed drug Orphan designation Priority review
First approval1978-04-17
Most recent approval2026-03-04
Brand namesCALCIMAR, CALCITONIN-SALMON, CIBACALCIN, FORTICAL, MIACALCIN
SponsorsAMNEAL, APOTEX INC, CIPLA, CUSTOPHARM INC, DR REDDYS
Marketing statusDiscontinued, Prescription
RoutesINJECTION, NASAL
Dosage formsINJECTABLE, SPRAY, METERED
Strengths0.5MG/VIAL, 100 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 200 IU/ML, 200 IU/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 200 IU/SPRAY, 200 IU/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 400 IU/VIAL
Therapeutic equivalenceAB, AP
FDA applicationsANDA073690, ANDA076396, ANDA076979, ANDA209358, ANDA212416, ANDA212675, ANDA213766, ANDA215715
Label supplements89
RxCUI308866
UNII7SFC6U2VI5
Drug classCalcitonin [EPC]
Carfilzomib
FDA-approvedReference listed drug Orphan designation Priority review
First approval2012-07-20
Most recent approval2026-07-20
Brand namesCARFILZOMIB, KITPROZY, KYPROLIS
SponsorsAMNEAL PHARMS NY, APOTEX, BRECKENRIDGE, DR REDDYS, EUGIA PHARMA
Marketing statusDiscontinued, None (Tentative Approval), Prescription
RoutesINJECTION, INTRAVENOUS, SINGLE-USE
Dosage formsINJECTABLE, POWDER, VIAL
Strengths10MG/VIAL, 120MG/2ML (60MG/ML), 2ML, 30MG, 30MG/VIAL, 60MG, 60MG/1VIAL, 60MG/ML, 2/ML, 60MG/VIAL
Therapeutic equivalenceAP
FDA applicationsANDA209330, ANDA209422, ANDA209425, ANDA209526, ANDA209528, ANDA210823, ANDA211185, ANDA219276
Label supplements35
Pending generics6
RxCUI1806934
UNII72X6E3J5AR
Drug classProteasome Inhibitor [EPC]
Cetrorelix
FDA-approvedReference listed drug
First approval2000-08-11
Most recent approval2026-04-29
Brand namesCETRORELIX ACETATE, CETROTIDE
SponsorsEMD SERONO INC, EPIC PHARMA LLC, GLAND, LIVZON GRP, QILU
Marketing statusDiscontinued, Prescription
RoutesSUBCUTANEOUS
Dosage formsPOWDER
StrengthsEQ 0.25MG BASE/VIAL, EQ 3MG BASE/VIAL
Therapeutic equivalenceAP
FDA applicationsANDA214540, ANDA215737, ANDA217776, ANDA218061, ANDA218150, ANDA218740, NDA021197
Label supplements16
RxCUI283402
Corticorelin
FDA-approvedOrphan designation Priority review
First approval1996-05-23
Brand namesACTHREL
SponsorsFERRING
Marketing statusPrescription
RoutesINJECTION
Dosage formsINJECTABLE
StrengthsEQ 0.1MG BASE/VIAL
FDA applicationsBLA020162
Label supplements5
Cosyntropin
FDA-approvedReference listed drug
First approval1970-04-22
Most recent approval2012-06-29
Brand namesCORTROSYN, COSYNTROPIN
SponsorsAMPHASTAR PHARMS INC, PHARMOBEDIENT, SANDOZ
Marketing statusDiscontinued, Prescription
RoutesINJECTION, INTRAVENOUS
Dosage formsINJECTABLE, SOLUTION
Strengths0.25MG/ML (0.25MG/ML), 0.25MG/VIAL
Therapeutic equivalenceAP
FDA applicationsANDA090574, ANDA202147, NDA016750, NDA022028
Label supplements25
UNII72YY86EA29
Drug classAdrenocorticotropic Hormone [EPC]
Degarelix
FDA-approvedReference listed drug
First approval2008-12-24
Brand namesDEGARELIX ACETATE, FIRMAGON
SponsorsCHIA TAI TIANQING PHARMACEUTICAL GROUP CO., LTD., FERRING
Marketing statusNone (Tentative Approval), Prescription
RoutesSUBCUTANEOUS
Dosage formsNJECTION, POWDER, LYOPHILIZED, FOR SOLUTION, POWDER
Strengths80MG, EQ 120MG BASE/VIAL, EQ 80MG BASE/VIAL
FDA applicationsANDA215791, NDA022201
Label supplements12
Pending generics1
RxCUI828749
Desmopressin
FDA-approvedReference listed drug Orphan designation Priority review
First approval1978-02-21
Most recent approval2026-02-27
Brand namesCONCENTRAID, DDAVP, DDAVP (NEEDS NO REFRIGERATION), DESMODA, DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE PRESERVATIVE FREE, MINIRIN
SponsorsABHAI LLC, ACERUS PHARMS, ACTAVIS LABS FL INC, AM REGENT, APOTEX
Marketing statusDiscontinued, Prescription
RoutesINJECTION, NASAL, ORAL, SUBLINGUAL
Dosage formsINJECTABLE, SOLUTION, SPRAY, METERED, TABLET
Strengths0.00083MG/SPRAY, 0.00166MG/SPRAY, 0.004MG/ML, 0.01%, 0.015MG/ML, 0.01MG/SPRAY, 0.01MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 0.0277MG
Therapeutic equivalenceAB, AP
FDA applicationsANDA074574, ANDA074575, ANDA074830, ANDA074888, ANDA075220, ANDA076470, ANDA076703, ANDA077122
Label supplements117
RxCUI833008
UNIIXB13HYU18U
Dulaglutide
FDA-approvedPriority review
First approval2014-09-18
Brand namesTRULICITY
SponsorsELI LILLY AND CO
Marketing statusPrescription
RoutesINJECTION
Dosage formsINJECTABLE
Strengths0.75MG/0.5ML, 1.5MG/0.5ML, 3MG/0.5ML, 4.5MG/0.5ML
FDA applicationsBLA125469
Label supplements21
RxCUI1551295
UNIIWTT295HSY5
Drug classGLP-1 Receptor Agonist [EPC]
Eptifibatide
FDA-approvedReference listed drug Priority review
First approval1998-05-18
Most recent approval2024-05-09
Brand namesEPTIFIBATIDE, INTEGRILIN
SponsorsACCORD HLTHCARE, BAXTER HLTHCARE CORP, EUGIA PHARMA, HAINAN POLY, HYBIO
Marketing statusDiscontinued, Prescription
RoutesINJECTION
Dosage formsINJECTABLE
Strengths2MG/ML, 2MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 75MG/100ML, 75MG/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Therapeutic equivalenceAP
FDA applicationsANDA090854, ANDA091555, ANDA203258, ANDA204361, ANDA204362, ANDA204589, ANDA204693, ANDA205557
Label supplements29
RxCUI200349
UNIINA8320J834
Drug classPlatelet Aggregation Inhibitor [EPC]
Exenatide
FDA-approvedReference listed drug Priority review
First approval2005-04-28
Most recent approval2024-11-19
Brand namesBYDUREON, BYDUREON BCISE, BYDUREON PEN, BYETTA, EXENATIDE SYNTHETIC
SponsorsAMNEAL, AMYLIN, ASTRAZENECA AB
Marketing statusDiscontinued, Prescription
RoutesSUBCUTANEOUS
Dosage formsFOR SUSPENSION, EXTENDED RELEASE, INJECTABLE, SUSPENSION, EXTENDED RELEASE
Strengths2MG, 2MG/0.85ML (2MG/0.85ML), 2MG/VIAL, 300MCG/1.2ML (250MCG/ML), 300UGM/1.2ML (250UGM/ML), 600MCG/2.4ML (250MCG/ML), 600UGM/2.4ML (250UGM/ML)
Therapeutic equivalenceAP
FDA applicationsANDA206697, NDA021773, NDA021919, NDA022200, NDA209210
Label supplements82
RxCUI847910
UNII9P1872D4OL
Drug classGLP-1 Receptor Agonist [EPC]
FDA documents (152 total)
Label 2025Letter 2025Label 2025Medication Guide 2025Label 2025Medication Guide 2025Ganirelix
FDA-approvedReference listed drug Priority review
First approval1999-07-29
Most recent approval2025-06-27
Brand namesFYREMADEL, GANIRELIX ACETATE
SponsorsAMPHASTAR PHARMS INC, GLAND, LUPIN, MEITHEAL, ORGANON USA ORGANON
Marketing statusDiscontinued, Prescription
RoutesINJECTION
Dosage formsINJECTABLE
Strengths250MCG/0.5ML
Therapeutic equivalenceAP
FDA applicationsANDA204246, ANDA212613, ANDA214996, ANDA215658, ANDA216075, ANDA218855, ANDA219454, NDA021057
Label supplements20
RxCUI855200
UNII56U7906FQW
Glucagon
FDA-approvedReference listed drug Priority review
First approval1960-11-14
Most recent approval2025-09-15
Brand namesBAQSIMI, GLUCAGEN, GLUCAGON, GVOKE HYPOPEN, GVOKE KIT, GVOKE PFS, GVOKE VIALDX
SponsorsAMPHASTAR PHARMS INC, CIPLA, FRESENIUS KABI USA, LILLY, LUPIN
Marketing statusDiscontinued, Prescription
RoutesINJECTION, INTRAMUSCULAR, INTRAVENOUS, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, Injection, NASAL
Dosage formsINJECTABLE, Injectable, POWDER, SOLUTION
Strengths0.5MG/0.1ML (0.5MG/0.1ML), 1MG/0.2ML (1MG/0.2ML), 1MG/VIAL, 1MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 3MG, EQ 10MG BASE/VIAL, EQ 10MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, EQ 1MG BASE/VIAL
Therapeutic equivalenceAP
FDA applicationsANDA071022, ANDA071023, ANDA204468, ANDA208086, ANDA214457, ANDA218813, NDA012122, NDA020918
Label supplements83
RxCUI310497
UNII1H87NVF4DB
Drug classAntihypoglycemic Agent [EPC]; Gastrointestinal Motility Inhibitor [EPC]
Goserelin
FDA-approvedReference listed drug
First approval1989-12-29
Most recent approval1996-01-11
Brand namesZOLADEX
SponsorsTERSERA
Marketing statusPrescription
RoutesIMPLANTATION
Dosage formsIMPLANT
Strengths3.6MG, EQ 10.8MG BASE, EQ 3.6MG BASE
FDA applicationsNDA019726, NDA020515, NDA020578
Label supplements75
RxCUI211544
UNII6YUU2PV0U8
Icatibant
FDA-approvedReference listed drug Orphan designation Priority review
First approval2011-08-25
Most recent approval2024-06-14
Brand namesFIRAZYR, ICATIBANT ACETATE
SponsorsALEMBIC, CAPLIN, CIPLA, EUGIA PHARMA, FRESENIUS KABI USA
Marketing statusDiscontinued, Prescription
RoutesSUBCUTANEOUS
Dosage formsINJECTABLE
StrengthsEQ 30MG BASE/3ML (EQ 10MG BASE/ML)
Therapeutic equivalenceAP
FDA applicationsANDA208317, ANDA210118, ANDA211021, ANDA211501, ANDA212081, ANDA212446, ANDA213054, ANDA213222
Label supplements21
RxCUI1148141
UNII325O8467XK
Insulin
FDA-approvedReference listed drug Orphan designation Priority review
First approval1982-10-28
Most recent approval2026-09-15
Brand namesADMELOG, ADMELOG SOLOSTAR, AFREZZA, APIDRA, APIDRA SOLOSTAR, AWIQLI FLEXTOUCH, BASAGLAR, FIASP
SponsorsBAXTER HLTHCARE CORP, BIOCON BIOLOGICS INC, ELI LILLY AND CO, ELI LILLY CO, EMERGE BIOSCIENCE PTE. LTD.
Marketing statusDiscontinued, Over-the-counter, Prescription
RoutesINHALATION, INJECTION, INTRAVENOUS, INTRAVENOUS, SUBCUTANEOUS, MULTIDOSE, PREFILLED
Dosage formsINJECTABLE, INJECTION, PEN, POWDER, SOLUTION, VIAL
Strengths10.8MG/3ML (100 UNITS/ML, 100 UNITS/100ML (1 UNIT/ML), 100 UNITS/ML, 1000 UNITS/10ML (100 UNITS/ML), 10000 UNITS/20ML (500 UNITS/ML), 100UNITS/ML, 100UNITS/ML(U-100), 10ML
FDA applicationsBLA018780, BLA018781, BLA019717, BLA019938, BLA019959, BLA019991, BLA020563, BLA020986
Label supplements868
RxCUI847230
UNII2ZM8CX04RZ
Drug classInsulin Analog [EPC]
Lanreotide
FDA-approvedReference listed drug Orphan designation Priority review
First approval2007-08-30
Most recent approval2024-05-21
Brand namesLANREOTIDE ACETATE, SOMATULINE DEPOT
SponsorsINVAGEN PHARMS, IPSEN PHARMA
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
StrengthsEQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML), EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML), EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
Therapeutic equivalenceAB
FDA applicationsANDA217193, NDA022074, NDA215395
Label supplements21
RxCUI749811
UNIIIEU56G3J9C
Leuprolide
FDA-approvedReference listed drug Orphan designation Priority review
First approval1985-04-09
Most recent approval2026-08-26
Brand namesCAMCEVI ETM, CAMCEVI KIT, ELIGARD KIT, FENSOLVI KIT, LEUPROLIDE ACETATE, LEUPROLIDE ACETATE FOR DEPOT SUSPENSION, LUPANETA PACK, LUPRON
SponsorsABBVIE ENDOCRINE, ABBVIE ENDOCRINE INC, ACCORD, AMNEAL, EUGIA PHARMA
Marketing statusDiscontinued, Prescription
RoutesIMPLANTATION, INJECTION, INTRAMUSCULAR, INTRAMUSCULAR, ORAL, SUBCUTANEOUS
Dosage formsEMULSION, FOR SUSPENSION, IMPLANT, INJECTABLE, INJECTABLE, TABLET, POWDER
Strengths11.25MG, 11.25MG/VIAL,N/A, 14MG/2.8ML (1MG/0.2ML), 14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 15MG, 22.5MG, 22.5MG/VIAL, 28MG/2.8ML (10MG/ML)
Therapeutic equivalenceAP
FDA applicationsANDA074728, ANDA075471, ANDA075721, ANDA078885, ANDA212963, ANDA213829, ANDA215336, ANDA215826
Label supplements411
RxCUI752889
UNII37JNS02E7V
Linaclotide
FDA-approvedReference listed drug Priority review
First approval2012-08-30
Most recent approval2023-02-07
Brand namesLINACLOTIDE, LINZESS
SponsorsABBVIE, ACTAVIS LABS FL INC, AUROBINDO PHARMA, MYLAN
Marketing statusDiscontinued, None (Tentative Approval), Prescription
RoutesORAL
Dosage formsCAPSULE
Strengths145MCG, 290MCG, 72MCG
Therapeutic equivalenceAB
FDA applicationsANDA209564, ANDA209611, ANDA211255, NDA202811
Label supplements22
Pending generics1
RxCUI1307409
UNIIN0TXR0XR5X
Drug classGuanylate Cyclase-C Agonist [EPC]
Liraglutide
FDA-approvedReference listed drug Priority review
First approval2010-01-25
Most recent approval2026-07-01
Brand namesLIRAGLUTIDE, SAXENDA, VICTOZA, XULTOPHY 100/3.6
SponsorsBIOCON PHARMA, FRESENIUS KABI USA, HIKMA, LUPIN, MYLAN INSTITUTIONAL
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
Strengths10.8MG/3ML (100 UNITS/ML, 18MG/3ML (6MG/ML), 300 UNITS/3ML
Therapeutic equivalenceAP1, AP2
FDA applicationsANDA212552, ANDA212972, ANDA213155, ANDA214568, ANDA215245, ANDA215421, ANDA215503, ANDA217063
Label supplements63
RxCUI897122
UNII839I73S42A
Drug classGLP-1 Receptor Agonist [EPC]
Lixisenatide
FDA-approvedPriority review
First approval2016-07-27
Most recent approval2016-11-21
Brand namesADLYXIN, SOLIQUA 100/33
SponsorsSANOFI-AVENTIS US
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
Strengths0.15MG/3ML (0.05MG/ML), 0.3MG/3ML (0.1MG/ML), 300 UNITS/3ML, 99MCG/3ML (100 UNITS/ML
FDA applicationsBLA208471, BLA208673
Label supplements17
RxCUI1858995
UNII2ZM8CX04RZ
Drug classInsulin Analog [EPC]; GLP-1 Receptor Agonist [EPC]
FDA documents (41 total)
Label 2026Label 2026Letter 2026Letter 2026Medication Guide 2026Medication Guide 2026Octreotide
FDA-approvedReference listed drug Orphan designation Priority review
First approval1988-10-21
Most recent approval2025-12-12
Brand namesBYNFEZIA PEN, MYCAPSSA, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE PRESERVATIVE FREE, SANDOSTATIN, SANDOSTATIN LAR
SponsorsCHIESI, FRESENIUS KABI USA, GLAND, HERITAGE, MEITHEAL
Marketing statusDiscontinued, Prescription
RoutesINJECTION, ORAL, SUBCUTANEOUS
Dosage formsCAPSULE, DELAYED RELEASE, INJECTABLE, SOLUTION
StrengthsEQ 0.05MG BASE/ML, EQ 0.1MG BASE/ML, EQ 0.2MG BASE/ML, EQ 0.2MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, EQ 0.5MG BASE/ML, EQ 10MG BASE/VIAL, EQ 1MG BASE/ML, EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Therapeutic equivalenceAB, AP
FDA applicationsANDA075957, ANDA075959, ANDA076313, ANDA076330, ANDA077329, ANDA077330, ANDA077331, ANDA077372
Label supplements153
RxCUI312069
UNII75R0U2568I
Drug classSomatostatin Analog [EPC]
Oxytocin
FDA-approvedReference listed drug
First approval1980-04-17
Most recent approval2018-07-13
Brand namesOXYTOCIN, OXYTOCIN 10 USP UNITS IN DEXTROSE 5%, OXYTOCIN 20 USP UNITS IN DEXTROSE 5%, OXYTOCIN 5 USP UNITS IN DEXTROSE 5%, PITOCIN, SYNTOCINON
SponsorsABBOTT, DR REDDYS, FRESENIUS KABI USA, HIKMA, HIKMA FARMACEUTICA
Marketing statusDiscontinued, Prescription
RoutesINJECTION, NASAL
Dosage formsINJECTABLE, SOLUTION
Strengths100USP UNITS/10ML (10USP UNITS/ML), 10USP UNITS/ML, 10USP UNITS/ML (10USP UNITS/ML), 1USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 2USP UNITS/100ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 300USP UNITS/30ML (10USP UNITS/ML), 40USP UNITS/ML, 500USP UNITS/50ML (10USP UNITS/ML)
Therapeutic equivalenceAP
FDA applicationsANDA077453, ANDA091676, ANDA200219, NDA012285, NDA018243, NDA018245, NDA018248, NDA018261
Label supplements83
RxCUI238013
UNII1JQS135EYN
Drug classOxytocic [EPC]
Pasireotide
FDA-approvedReference listed drug Orphan designation
First approval2012-12-14
Most recent approval2014-12-15
Brand namesSIGNIFOR, SIGNIFOR LAR KIT
SponsorsRECORDATI RARE
Marketing statusPrescription
RoutesINTRAMUSCULAR, SUBCUTANEOUS
Dosage formsFOR SUSPENSION, SOLUTION
StrengthsEQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML), EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML), EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML), EQ 10MG BASE/VIAL, EQ 20MG BASE/VIAL, EQ 30MG BASE/VIAL, EQ 40MG BASE/VIAL, EQ 60MG BASE/VIAL
FDA applicationsNDA200677, NDA203255
Label supplements14
RxCUI1364109
UNII98H1T17066
Drug classSomatostatin Analog [EPC]
Plecanatide
FDA-approvedReference listed drug
First approval2017-01-19
Brand namesTRULANCE
SponsorsSALIX
Marketing statusPrescription
RoutesORAL
Dosage formsTABLET
Strengths3MG
FDA applicationsNDA208745
Label supplements5
RxCUI1873757
UNII7IK8Z952OK
Drug classGuanylate Cyclase-C Agonist [EPC]
FDA documents (15 total)
Label 2021Medication Guide 2021Letter 2021Label 2021Medication Guide 2021Letter 2021Romidepsin
FDA-approvedReference listed drug Orphan designation Priority review
First approval2009-11-05
Most recent approval2026-06-02
Brand namesISTODAX, ROMIDEPSIN
SponsorsAMNEAL, BRISTOL-MYERS, FRESENIUS KABI USA, TEVA PHARMS USA INC
Marketing statusDiscontinued, Prescription
RoutesINTRAVENOUS
Dosage formsPOWDER, SOLUTION
Strengths10MG/2ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 10MG/VIAL, 27.5MG/5.5ML (5MG/ML), 27.5MG/5.5ML (5MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Therapeutic equivalenceAP
FDA applicationsANDA206254, ANDA219099, NDA022393, NDA208574
Label supplements11
RxCUI877513
UNIICX3T89XQBK
Drug classHistone Deacetylase Inhibitor [EPC]
Secretin
FDA-approvedReference listed drug Orphan designation Priority review
First approval2002-04-04
Most recent approval2004-04-09
Brand namesCHIRHOSTIM, PORCINE SECRETIN, SECREFLO, SECRETIN-FERRING
SponsorsCHIRHOCLIN, FERRING
Marketing statusDiscontinued, Prescription
RoutesINJECTION, INTRAVENOUS, SUBCUTANEOUS LYOPHILIZED POWER
Dosage formsFOR SOLUTION, INJECTABLE
Strengths16MCG, 16MCG/VIAL, 40MCG, 40MCG/VIAL, 75CU/VIAL
FDA applicationsNDA018290, NDA021136, NDA021209, NDA021256
Label supplements14
RxCUI727488
UNIIA0426J905J
Semaglutide
FDA-approvedReference listed drug Priority review
First approval2017-12-05
Most recent approval2025-12-22
Brand namesOZEMPIC, RYBELSUS, SEMAGLUTIDE, WEGOVY, WEGOVY FLEXTOUCH, WEGOVY HD
SponsorsAPOTEX INC, NOVO, NOVO NORDISK INC
Marketing statusDiscontinued, None (Tentative Approval), Prescription
RoutesORAL, SOLUTION, SUBCUTANEOUS
Dosage formsINJECTION, SOLUTION, TABLET
Strengths0.25MG/0.5ML (0.25MG/0.5ML), 0.5MG/0.5ML (0.5MG/0.5ML), 1.5MG, 1.7MG/0.75ML (1.7MG/0.75ML), 14MG, 1MG/0.5ML (1MG/0.5ML), 2.4MG/0.75ML (2.4MG/0.75ML), 25MG
FDA applicationsANDA220314, NDA209637, NDA213051, NDA213182, NDA215256, NDA218316
Label supplements47
Pending generics1
RxCUI2200644
UNII53AXN4NNHX
Drug classGLP-1 Receptor Agonist [EPC]
Setmelanotide
FDA-approvedReference listed drug Orphan designation Priority review
First approval2020-11-25
Brand namesIMCIVREE
SponsorsRHYTHM
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
StrengthsEQ 10MG BASE/ML (EQ 10MG BASE/ML)
FDA applicationsNDA213793
Label supplements5
RxCUI2469346
UNIIN7T15V1FUY
Drug classMelanocortin 4 Receptor Agonist [EPC]
Somatrogon
FDA-approvedOrphan designation
First approval2023-06-27
Brand namesNGENLA
SponsorsPFIZER IRELAND PHARMACEUTICALS
Marketing statusPrescription
RoutesINJECTION
Dosage formsINJECTABLE
Strengths24MG, 60MG
FDA applicationsBLA761184
Label supplements4
RxCUI2644517
UNII6D848RA61B
Somatropin
FDA-approvedOrphan designation Priority review
First approval1986-10-16
Most recent approval2008-01-23
Brand namesACCRETROPIN, BIO-TROPIN, GENOTROPIN, GENOTROPIN PRESERVATIVE FREE, HUMATROPE, NORDITROPIN, NORDITROPIN FLEXPRO, NORDITROPIN NORDIFLEX
SponsorsEMD SERONO, EMERGENT, FERRING, GENENTECH, LILLY
Marketing statusDiscontinued, Prescription
RoutesINJECTION, Injection, SUBCUTANEOUS
Dosage formsINJECTABLE, Injectable
Strengths0.2MG/VIAL, 0.4MG/VIAL, 0.6MG/VIAL, 0.8MG/VIAL, 1.2MG/VIAL, 1.4MG/VIAL, 1.5MG/VIAL, 1.6MG/VIAL
FDA applicationsBLA019640, BLA019676, BLA019764, BLA019774, BLA020168, BLA020280, BLA020522, BLA020604
Label supplements393
RxCUI241975
UNIINQX9KB6PCL
Drug classRecombinant Human Growth Hormone [EPC]
Teduglutide
FDA-approvedReference listed drug Orphan designation Priority review
First approval2012-12-21
Brand namesGATTEX KIT
SponsorsTAKEDA PHARMS USA
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsPOWDER
Strengths5MG/VIAL
FDA applicationsNDA203441
Label supplements18
RxCUI1364472
UNII7M19191IKG
Drug classGLP-2 Analog [EPC]
Teriparatide
FDA-approvedReference listed drug
First approval2002-11-26
Most recent approval2025-12-12
Brand namesBONSITY, FORTEO, PARATHAR, TERIPARATIDE
SponsorsALMAJECT, ALVOGEN, AMPHASTAR PHARMS INC, APOTEX, LILLY
Marketing statusDiscontinued, Prescription
RoutesINJECTION, SUBCUTANEOUS
Dosage formsINJECTABLE, SOLUTION
Strengths0.56MG/2.24ML (0.25MG/ML), 0.75MG/3ML (0.25MG/ML), 200 UNITS/VIAL
Therapeutic equivalenceAP
FDA applicationsANDA208569, ANDA211097, ANDA213641, NDA019498, NDA021318, NDA211939, NDA218771
Label supplements32
RxCUI1435115
UNII10T9CSU89I
Drug classParathyroid Hormone Analog [EPC]
FDA documents (57 total)
Label 2026Medication Guide 2026Label 2026Medication Guide 2026Label 2026Medication Guide 2026Terlipressin
FDA-approvedReference listed drug Orphan designation Priority review
First approval2022-09-14
Brand namesTERLIVAZ
SponsorsMALLINCKRODT IRELAND
Marketing statusPrescription
RoutesINTRAVENOUS
Dosage formsPOWDER
StrengthsEQ 0.85MG BASE/VIAL
FDA applicationsNDA022231
Label supplements2
RxCUI2612431
UNII7Z5X49W53P
Drug classVasopressin Receptor Agonist [EPC]
Tesamorelin
FDA-approvedFirst approval2010-11-10
Brand namesEGRIFTA
SponsorsTHERATECHNOLOGIES
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsPOWDER
StrengthsEQ 1MG BASE/VIAL, EQ 2MG BASE/VIAL
FDA applicationsBLA022505
Label supplements12
RxCUI2719314
Tirzepatide
FDA-approvedReference listed drug Priority review
First approval2022-05-13
Most recent approval2023-11-08
Brand namesMOUNJARO, MOUNJARO (AUTOINJECTOR), MOUNJARO KWIKPEN, ZEPBOUND, ZEPBOUND (AUTOINJECTOR), ZEPBOUND KWIKPEN
SponsorsELI LILLY AND CO
Marketing statusPrescription
RoutesSUBCUTANEOUS
Dosage formsSOLUTION
Strengths10MG/0.5ML (10MG/0.5ML), 10MG/2.4ML (4.17MG/ML), 12.5MG/0.5ML (12.5MG/0.5ML), 15MG/0.5ML (15MG/0.5ML), 2.5MG/0.5ML (2.5MG/0.5ML), 20MG/2.4ML (8.33MG/ML), 30MG/2.4ML (12.5MG/ML), 40MG/2.4ML (16.7MG/ML)
FDA applicationsNDA215866, NDA217806
Label supplements27
RxCUI2601743
UNIIOYN3CCI6QE
Drug classGlucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]; GLP-1 Receptor Agonist [EPC]
Triptorelin
FDA-approvedReference listed drug Orphan designation
First approval2000-06-15
Most recent approval2017-06-29
Brand namesTRELSTAR, TRIPTODUR KIT
SponsorsAZURITY, VERITY
Marketing statusPrescription
RoutesINTRAMUSCULAR
Dosage formsFOR SUSPENSION, EXTENDED RELEASE, INJECTABLE
StrengthsEQ 11.25MG BASE/VIAL, EQ 22.5MG BASE/VIAL, EQ 3.75MG BASE/VIAL
FDA applicationsNDA020715, NDA021288, NDA022437, NDA208956
Label supplements63
RxCUI199821
Vasopressin
FDA-approvedReference listed drug
First approval2014-04-17
Most recent approval2026-05-06
Brand namesPITRESSIN TANNATE, VASOPRESSIN, VASOPRESSIN IN DEXTROSE 5%, VASOPRESSIN IN SODIUM CHLORIDE 0.9%, VASOSTRICT
SponsorsAM REGENT, AMNEAL, AMNEAL EU LTD, AMPHASTAR PHARMS INC, BAXTER HLTHCARE CORP
Marketing statusDiscontinued, None (Tentative Approval), Prescription
RoutesINJECTION, INTRAVENOUS
Dosage formsINJECTABLE, SOLUTION
Strengths200UNITS/10ML (20UNITS/ML), 200UNITS/10ML(20UNITS/ML), 20UNITS/100ML (0.2UNITS/ML), 20UNITS/ML (20UNITS/ML), 40UNITS/100ML (0.4UNITS/ML), 50UNITS/50ML (1UNIT/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, 50UNITS/50ML (1UNITS/ML), 5PRESSOR UNITS/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Therapeutic equivalenceAP
FDA applicationsANDA211538, ANDA211857, ANDA212068, ANDA212069, ANDA212944, ANDA212945, ANDA213206, ANDA213988
Label supplements19
Pending generics1
RxCUI2399907
UNIIY4907O6MFD
Ziconotide
FDA-approvedReference listed drug Priority review
First approval2004-12-28
Brand namesPRIALT
SponsorsESTEVE
Marketing statusDiscontinued, Prescription
RoutesINTRATHECAL
Dosage formsINJECTABLE
Strengths100MCG/1ML (100MCG/ML), 200MCG/2ML (100MCG/ML), 500MCG/20ML (25MCG/ML), 500MCG/5ML (100MCG/ML)
FDA applicationsNDA021060
Label supplements5
RxCUI486133
UNIIT2I226K69M
Approved, then discontinued (5)
These were genuinely FDA-approved, then withdrawn from marketing. Their approval history is why a search engine may still describe them as approved drugs.
Enfuvirtide
Approved, then discontinuedReference listed drug Priority review
First approval2003-03-13
Brand namesFUZEON
SponsorsROCHE
Marketing statusDiscontinued
RoutesSUBCUTANEOUS
Dosage formsINJECTABLE
Strengths90MG/VIAL
FDA applicationsNDA021481
Label supplements17
Macimorelin
Approved, then discontinuedReference listed drug Orphan designation Priority review
First approval2017-12-20
Brand namesMACRILEN
SponsorsAETERNA ZENTARIS
Marketing statusDiscontinued
RoutesORAL
Dosage formsFOR SOLUTION
StrengthsEQ 60MG BASE/POUCH
FDA applicationsNDA205598
Label supplements2
UNII8680B21W73
Drug classGrowth Hormone Secretagogue Receptor Agonist [EPC]
Nesiritide
Approved, then discontinuedReference listed drug
First approval2001-08-10
Brand namesNATRECOR
SponsorsSCIOS LLC
Marketing statusDiscontinued
RoutesINTRAVENOUS
Dosage formsFOR SOLUTION
Strengths1.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FDA applicationsNDA020920
Label supplements13
Pramlintide
Approved, then discontinuedReference listed drug
First approval2005-03-16
Brand namesSYMLIN
SponsorsASTRAZENECA AB
Marketing statusDiscontinued
RoutesSUBCUTANEOUS
Dosage formsINJECTABLE
StrengthsEQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML), EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML), EQ 3MG BASE/5ML (EQ 600MCG BASE/ML)
FDA applicationsNDA021332
Label supplements10
RxCUI861042
UNII726I6TE06G
Sermorelin
Approved, then discontinuedReference listed drug Orphan designation
First approval1990-12-28
Most recent approval1997-09-26
Brand namesGEREF
SponsorsEMD SERONO, EMD SERONO INC
Marketing statusDiscontinued
RoutesINJECTION
Dosage formsINJECTABLE
StrengthsEQ 0.05MG BASE/AMP **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, EQ 0.5MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, EQ 1MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
FDA applicationsNDA019863, NDA020443
Label supplements5
Never FDA-approved (15)
No Drugs@FDA record exists. These are the compounds most often sold as research chemicals.
Aod 9604
Never FDA-approvedNo Drugs@FDA record exists for Aod 9604. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Bpc 157
Never FDA-approvedNo Drugs@FDA record exists for Bpc 157. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Cjc 1295
Never FDA-approvedNo Drugs@FDA record exists for Cjc 1295. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Epitalon
Never FDA-approvedNo Drugs@FDA record exists for Epitalon. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Ghrp 2
Never FDA-approvedNo Drugs@FDA record exists for Ghrp 2. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Ghrp 6
Never FDA-approvedNo Drugs@FDA record exists for Ghrp 6. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Hexarelin
Never FDA-approvedNo Drugs@FDA record exists for Hexarelin. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Ipamorelin
Never FDA-approvedNo Drugs@FDA record exists for Ipamorelin. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Melanotan
Never FDA-approvedNo Drugs@FDA record exists for Melanotan. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Mots C
Never FDA-approvedNo Drugs@FDA record exists for Mots C. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Selank
Never FDA-approvedNo Drugs@FDA record exists for Selank. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Semax
Never FDA-approvedNo Drugs@FDA record exists for Semax. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Ss 31
Never FDA-approvedNo Drugs@FDA record exists for Ss 31. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Tb 500
Never FDA-approvedNo Drugs@FDA record exists for Tb 500. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Thymosin Beta 4
Never FDA-approvedNo Drugs@FDA record exists for Thymosin Beta 4. It has never been approved by the FDA as a drug for human use, in any form, for any indication. It is not a generic of an approved product and has not been evaluated by the FDA for safety, effectiveness, or quality.
Frequently asked questions
Which peptides are FDA-approved?
As of 2026-09-23, 47 of the 62 peptides tracked on this page have at least one FDA-approved application, 5 were approved and later discontinued, and 15 have no FDA record at all.
Does “not FDA-approved” mean illegal?
No. Not FDA-approved means the FDA has not reviewed and cleared that product as a drug for human use. It is not the same as being illegal to possess everywhere, and it is not the same as being unapproved in every country. It does mean the product has not been evaluated by the FDA for safety, effectiveness, or quality.
What is a tentative approval?
It means the FDA has judged a generic application to meet its approval standards, but cannot let it be marketed yet, usually because patents or exclusivity on the brand product have not expired. It is a reliable signal that a generic is coming.
Why does this page list discontinued drugs?
Because approval status and marketing status are different things. Sermorelin, for example, was FDA-approved in 1990 and later discontinued. Looking a drug up only among currently marketed products would wrongly report it as never approved.
Where does this data come from?
Drugs@FDA through the openFDA API, published by the U.S. Food and Drug Administration. Each peptide is looked up by FDA active-ingredient name, which includes withdrawn and discontinued products. A peptide with no Drugs@FDA record is reported as never FDA-approved.
Source: Drugs@FDA via openFDA, U.S. Food and Drug Administration. Each peptide is looked up by FDA active-ingredient name, which includes withdrawn and discontinued products. Last updated 2026-09-23. Do not rely on this page to make decisions regarding medical care; always speak to your health provider about the risks and benefits of FDA-regulated products.