Treats growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome…. BLA 20280, held by Pharmacia. Somatropin.
As of Nov 13, 2026, BLA 20280 (Genotropin Preservative Free, Genotropin), held by Pharmacia, was first approved by FDA on Aug 24, 1995, with 64 approved supplements and 0 published complete response letters.
GENOTROPIN is a recombinant human growth hormone indicated for:
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 12, 2008 | Supplement 60Efficacy (new indication or use) | Approved | |
| Apr 27, 2006 | Supplement 49Efficacy (new indication or use) | Approved | |
| Jul 25, 2001 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Jun 20, 2000 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | |
| Oct 31, 1997 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 24, 1995 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Genotropin Preservative Free0.2MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free0.4MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free0.6MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free1.5MG/VIAL · injectable;injection | Somatropin | Discontinued |
| Genotropin Preservative Free0.8MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin5.8MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin13.8MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free1MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free1.2MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free1.4MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free1.6MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free1.8MG/VIAL · injectable;injection | Somatropin | Rx |
| Genotropin Preservative Free2MG/VIAL · injectable;injection | Somatropin | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 9, 2025 | Supplement 108Labeling · Standard review | Approved | |
| Aug 16, 2024 | Supplement 92Labeling · Standard review | Approved | |
| Jan 8, 2020 | Supplement 90Labeling · Standard review | Approved | |
| Jan 27, 2017 | Supplement 87Manufacturing · Standard review | Approved | None posted |
| Dec 13, 2016 | Supplement 88Labeling · Standard review | Approved | |
| Sep 6, 2016 | Supplement 79Labeling · Standard review | Approved | |
| Jun 16, 2016 | Supplement 84Manufacturing · Standard review | Approved | None posted |
| Dec 28, 2015 | Supplement 82Manufacturing · Standard review | Approved | None posted |
| Sep 10, 2015 | Supplement 81Manufacturing · Standard review | Approved | None posted |
| Jun 22, 2015 | Supplement 78Labeling · Standard review | Approved | |
| Feb 16, 2015 | Supplement 80Manufacturing · Standard review | Approved | None posted |
| Sep 25, 2014 | Supplement 77Labeling · Standard review | Approved | |
| Oct 17, 2013 | Supplement 75Manufacturing · Standard review | Approved | None posted |
| Apr 19, 2013 | Supplement 74Manufacturing · Standard review | Approved | None posted |
| Feb 6, 2012 | Supplement 72Labeling | Approved | |
| May 17, 2011 | Supplement 71Labeling | Approved | |
| Feb 2, 2010 | Supplement 68Labeling | Approved | |
| May 20, 2009 | Supplement 64Manufacturing | Approved | |
| Jan 5, 2009 | Supplement 61Manufacturing | Approved | |
| Dec 15, 2008 | Supplement 66Labeling · Standard review | Approved | |
| Jun 12, 2008 | Supplement 60Efficacy (new indication or use) | Approved | |
| Jul 22, 2007 | Supplement 55Manufacturing | Approved | |
| Mar 14, 2007 | Supplement 57Labeling · Standard review | Approved | |
| Apr 27, 2006 | Supplement 49Efficacy (new indication or use) | Approved | |
| Oct 31, 2003 | Supplement 44Labeling · Standard review | Approved | |
| May 12, 2003 | Supplement 40Manufacturing · Standard review | Approved | |
| Mar 28, 2003 | Supplement 38Manufacturing · Standard review | Approved | |
| Nov 5, 2002 | Supplement 41Manufacturing · Standard review | Approved | None posted |
| Aug 15, 2002 | Supplement 39Manufacturing · Standard review | Approved | None posted |
| Jan 29, 2002 | Supplement 37Manufacturing · Standard review | Approved | None posted |
| Sep 21, 2001 | Supplement 36Manufacturing · Standard review | Approved | None posted |
| Jul 25, 2001 | Supplement 31Efficacy (new indication or use) · Priority review | Approved | |
| Jul 9, 2001 | Supplement 35Manufacturing · Standard review | Approved | None posted |
| Jan 26, 2001 | Supplement 34Manufacturing · Standard review | Approved | None posted |
| Dec 8, 2000 | Supplement 33Manufacturing · Standard review | Approved | None posted |
| Nov 7, 2000 | Supplement 32Manufacturing · Standard review | Approved | None posted |
| Oct 5, 2000 | Supplement 29Manufacturing · Standard review | Approved | None posted |
| Aug 18, 2000 | Supplement 28Labeling · Standard review | Approved | None posted |
| Jul 31, 2000 | Supplement 27Manufacturing · Standard review | Approved | None posted |
| Jul 21, 2000 | Supplement 30Manufacturing · Standard review | Approved | None posted |
| Jul 11, 2000 | Supplement 21Manufacturing · Standard review | Approved | None posted |
| Jul 11, 2000 | Supplement 25Labeling · Standard review | Approved | None posted |
| Jun 20, 2000 | Supplement 23Efficacy (new indication or use) · Priority review | Approved | |
| May 26, 2000 | Supplement 26Manufacturing · Standard review | Approved | None posted |
| May 12, 2000 | Supplement 24Manufacturing · Standard review | Approved | None posted |
| Apr 11, 2000 | Supplement 22Manufacturing · Standard review | Approved | None posted |
| Jan 19, 2000 | Supplement 20Manufacturing · Standard review | Approved | None posted |
| Apr 30, 1999 | Supplement 13Manufacturing · Standard review | Approved | None posted |
| Apr 30, 1999 | Supplement 18Manufacturing · Standard review | Approved | None posted |
| Apr 27, 1999 | Supplement 17Manufacturing · Standard review | Approved | None posted |
| Feb 24, 1999 | Supplement 16Manufacturing · Standard review | Approved | None posted |
| Aug 18, 1998 | Supplement 12Manufacturing · Standard review | Approved | None posted |
| Aug 4, 1998 | Supplement 11Manufacturing · Standard review | Approved | None posted |
| Jul 30, 1998 | Supplement 15Manufacturing · Standard review | Approved | None posted |
| Jan 27, 1998 | Supplement 9Manufacturing · Standard review | Approved | None posted |
| Jan 5, 1998 | Supplement 10Manufacturing · Standard review | Approved | None posted |
| Oct 31, 1997 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Nov 19, 1996 | Supplement 6Manufacturing · Standard review | Approved | None posted |
| Oct 23, 1996 | Supplement 7Manufacturing · Standard review | Approved | None posted |
| Jul 15, 1996 | Supplement 5Manufacturing · Standard review | Approved | None posted |
| May 24, 1996 | Supplement 4Manufacturing · Standard review | Approved | None posted |
| Apr 24, 1996 | Supplement 2Manufacturing · Standard review | Approved | None posted |
| Apr 19, 1996 | Supplement 3Labeling · Standard review | Approved | None posted |
| Dec 20, 1995 | Supplement 1Labeling · Standard review | Approved | None posted |
| Aug 24, 1995 | Original applicationNew formulation or manufacturer · Standard review | Approved | None posted |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
