← FDA DRUG APPROVALS

FDA BLA · BLA020280

GENOTROPIN

somatropin

Sponsor: PHARMACIA

APPLICATION
BLA020280
TYPE
BLA
ORIGINAL APPROVAL
1995-08-24
LATEST ACTION
2025-07-09
ROUTE
INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 1.6MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 0.6MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 0.2MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 1MG/VIAL · INJECTABLE · INJECTION
GENOTROPINPrescription
SOMATROPIN 5.8MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 1.8MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEDiscontinued
SOMATROPIN 1.5MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 1.4MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 0.4MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 1.2MG/VIAL · INJECTABLE · INJECTION
GENOTROPINPrescription
SOMATROPIN 13.8MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 2MG/VIAL · INJECTABLE · INJECTION
GENOTROPIN PRESERVATIVE FREEPrescription
SOMATROPIN 0.8MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-07-09Labeling · Supplement 108 · standard — Letter ↗AP
2024-08-16Labeling · Supplement 92 · standard — Letter ↗AP
2020-01-08Labeling · Supplement 90 · standard — Other ↗AP
2017-01-27Manufacturing (CMC) · Supplement 87 · standardAP
2016-12-13Labeling · Supplement 88 · standard — Label ↗AP
2016-09-06Labeling · Supplement 79 · standard — Letter ↗AP
2016-06-16Manufacturing (CMC) · Supplement 84 · standardAP
2015-12-28Manufacturing (CMC) · Supplement 82 · standardAP
2015-09-10Manufacturing (CMC) · Supplement 81 · standardAP
2015-06-22Labeling · Supplement 78 · standard — Letter ↗AP
2015-02-16Manufacturing (CMC) · Supplement 80 · standardAP
2014-09-25Labeling · Supplement 77 · standard — Label ↗AP
2013-10-17Manufacturing (CMC) · Supplement 75 · standardAP
2013-04-19Manufacturing (CMC) · Supplement 74 · standardAP
2012-02-06Labeling · Supplement 72 · unknown — Letter ↗AP
2011-05-17Labeling · Supplement 71 · unknown — Label ↗AP
2010-02-02Labeling · Supplement 68 · unknown — Label ↗AP
2009-05-20Manufacturing (CMC) · Supplement 64 — Letter ↗AP
2009-01-05Manufacturing (CMC) · Supplement 61 — Label ↗AP
2008-12-15Labeling · Supplement 66 · standard — Label ↗AP
2008-06-12Efficacy · Supplement 60 · unknown — Letter ↗AP
2007-07-22Manufacturing (CMC) · Supplement 55 — Label ↗AP
2007-03-14Labeling · Supplement 57 · standard — Label ↗AP
2006-04-27Efficacy · Supplement 49 · unknown — Label ↗AP
2003-10-31Labeling · Supplement 44 · standard — Letter ↗AP
2003-05-12Manufacturing (CMC) · Supplement 40 · standard — Letter ↗AP
2003-03-28Manufacturing (CMC) · Supplement 38 · standard — Letter ↗AP
2002-11-05Manufacturing (CMC) · Supplement 41 · standardAP
2002-08-15Manufacturing (CMC) · Supplement 39 · standardAP
2002-01-29Manufacturing (CMC) · Supplement 37 · standardAP
2001-09-21Manufacturing (CMC) · Supplement 36 · standardAP
2001-07-25Efficacy · Supplement 31 · priority — Label ↗AP
2001-07-09Manufacturing (CMC) · Supplement 35 · standardAP
2001-01-26Manufacturing (CMC) · Supplement 34 · standardAP
2000-12-08Manufacturing (CMC) · Supplement 33 · standardAP
2000-11-07Manufacturing (CMC) · Supplement 32 · standardAP
2000-10-05Manufacturing (CMC) · Supplement 29 · standardAP
2000-08-18Labeling · Supplement 28 · standardAP
2000-07-31Manufacturing (CMC) · Supplement 27 · standardAP
2000-07-21Manufacturing (CMC) · Supplement 30 · standardAP
VIEW ON DRUGS@FDA ↗

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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