← FDA DRUG APPROVALS

FDA BLA · BLA021426

OMNITROPE

somatropin

Sponsor: SANDOZ

APPLICATION
BLA021426
TYPE
BLA
ORIGINAL APPROVAL
2006-05-30
LATEST ACTION
2025-07-09
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

OMNITROPEPrescription
SOMATROPIN 5MG/1.5ML · INJECTABLE · INJECTION
OMNITROPEPrescription
SOMATROPIN 5.8MG/VIAL · INJECTABLE · INJECTION
OMNITROPEPrescription
SOMATROPIN 10MG/1.5ML · INJECTABLE · INJECTION
OMNITROPEPrescription
SOMATROPIN 1.5MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-07-09Labeling · Supplement 62 · standard — Letter ↗AP
2024-11-12Labeling · Supplement 43 · standard — Letter ↗AP
2024-11-12Labeling · Supplement 58 · standard — Letter ↗AP
2022-01-25Manufacturing (CMC) · Supplement 50 — Letter ↗AP
2017-02-15Labeling · Supplement 22 · standard — Label ↗AP
2016-12-13Labeling · Supplement 34 · standard — Letter ↗AP
2014-08-29Labeling · Supplement 28 · standard — Label ↗AP
2014-07-14Manufacturing (CMC) · Supplement 29 · standardAP
2013-08-22Manufacturing (CMC) · Supplement 27 · standardAP
2013-06-18Manufacturing (CMC) · Supplement 25 · standardAP
2013-04-04Manufacturing (CMC) · Supplement 23 · standardAP
2011-07-22Efficacy · Supplement 17 · standard — Label ↗AP
2011-04-13Labeling · Supplement 18 · unknown — Label ↗AP
2010-08-26Efficacy · Supplement 15 · standard — Label ↗AP
2010-04-23Efficacy · Supplement 8 · standard — Review ↗AP
2010-04-23Efficacy · Supplement 7 · standard — Letter ↗AP
2009-03-25Manufacturing (CMC) · Supplement 6 — Letter ↗AP
2008-08-25Manufacturing (CMC) · Supplement 4 — Review ↗AP
2008-01-16Manufacturing (CMC) · Supplement 2 — Label ↗AP
2006-05-30Type 5 - New Formulation or New Manufacturer · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

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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