← FDA DRUG APPROVALS

FDA BLA · BLA019774

ZOMACTON

somatropin

Sponsor: FERRING

APPLICATION
BLA019774
TYPE
BLA
ORIGINAL APPROVAL
1995-05-25
LATEST ACTION
2025-07-09
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

ZOMACTONPrescription
SOMATROPIN 10MG/VIAL · INJECTABLE · INJECTION
BIO-TROPINDiscontinued
SOMATROPIN 4.8MG/VIAL · INJECTABLE · INJECTION
ZOMACTONPrescription
SOMATROPIN 5MG/VIAL · INJECTABLE · INJECTION

Approval history

2025-07-09Labeling · Supplement 65 · standard — Letter ↗AP
2024-04-02Labeling · Supplement 63 · standard — Letter ↗AP
2020-03-13Labeling · Supplement 53 · standard — Other ↗AP
2018-07-19Efficacy · Supplement 49 · standard — Letter ↗AP
2018-07-19Efficacy · Supplement 51 · standard — Letter ↗AP
2018-07-19Efficacy · Supplement 48 · standard — Letter ↗AP
2018-07-19Efficacy · Supplement 50 · standard — Letter ↗AP
2018-01-30Labeling · Supplement 47 · standard — Letter ↗AP
2018-01-30Efficacy · Supplement 45 · standard — Letter ↗AP
2018-01-30Labeling · Supplement 29 · standard — Letter ↗AP
2018-01-30Efficacy · Supplement 40 · standard — Letter ↗AP
2017-01-10Labeling · Supplement 37 · standard — Letter ↗AP
2016-12-13Labeling · Supplement 38 · standard — Letter ↗AP
2016-09-30Labeling · Supplement 36 · standard — Label ↗AP
2016-02-26Manufacturing (CMC) · Supplement 34 · standardAP
2015-08-06Manufacturing (CMC) · Supplement 30 · standardAP
2015-07-30Manufacturing (CMC) · Supplement 32 · standardAP
2015-06-12Labeling · Supplement 31 · standard — Letter ↗AP
2015-03-04Labeling · Supplement 26 · standard — Letter ↗AP
2014-10-29Labeling · Supplement 28 · standard — Letter ↗AP
2014-06-18Labeling · Supplement 27 · standard — Letter ↗AP
2011-07-19Labeling · Supplement 23 · standard — Letter ↗AP
2010-04-12Labeling · Supplement 19 · unknown — Letter ↗AP
2009-06-25Manufacturing (CMC) · Supplement 16 — Letter ↗AP
2007-02-15Labeling · Supplement 14 · standard — Letter ↗AP
2005-03-16Labeling · Supplement 9 · standard — Review ↗AP
2002-04-09Manufacturing (CMC) · Supplement 7 · standardAP
2002-01-04Manufacturing (CMC) · Supplement 8 · standardAP
2000-08-17Labeling · Supplement 6 · standardAP
2000-02-03Manufacturing (CMC) · Supplement 5 · standardAP
1999-11-03Manufacturing (CMC) · Supplement 4 · standardAP
1996-09-09Manufacturing (CMC) · Supplement 3 · standardAP
1996-08-29Manufacturing (CMC) · Supplement 2 · standardAP
1995-05-25Type 5 - New Formulation or New Manufacturer · Original · 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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