Somatropin: FDA status and clinical evidence
Somatropin is approved by the FDA and is on the US market, first approved October 16, 1986, under 12 applications. 818 studies are registered on ClinicalTrials.gov, reaching Phase 4.
FDA approval status
FDA review documents
Clinical evidence
By phase
Molecular identity
NQX9KB6PCLFrom the FDA Global Substance Registration System, the registry that assigns every substance the FDA tracks a unique identifier.
Frequently asked questions
Is Somatropin FDA-approved?
Yes. Somatropin holds FDA approval and is marketed in the US. Approval covers the specific uses, doses and forms on the FDA label, not every use it is sold or discussed for.
How much clinical research is there on Somatropin?
818 studies are registered on ClinicalTrials.gov with Somatropin as an intervention, 393 of them completed. The highest phase reached is Phase 4. Registration counts research activity, not proven benefit.
What brand names is Somatropin sold under?
FDA records list ACCRETROPIN, BIO-TROPIN, GENOTROPIN, GENOTROPIN PRESERVATIVE FREE, HUMATROPE, NORDITROPIN, NORDITROPIN FLEXPRO, NORDITROPIN NORDIFLEX, NUTROPIN, NUTROPIN AQ, NUTROPIN AQ NUSPIN, NUTROPIN AQ PEN and 6 more. Brand availability changes over time, and some applications on file are marked discontinued.
Where does the information on this page come from?
Four FDA and NIH sources: Drugs@FDA for approval records, the FDA Orange Book for patents and exclusivity, the FDA Global Substance Registration System for molecular identity, and ClinicalTrials.gov for trial counts. Each is refreshed on a schedule and the date above shows the last refresh.
Sources: Drugs@FDA, FDA Orange Book, FDA Global Substance Registration System and ClinicalTrials.gov. Last refreshed 2026-10-16.