← FDA DRUG APPROVALS

FDA BLA · BLA020604

SEROSTIM

somatropin

Sponsor: EMD SERONO

APPLICATION
BLA020604
TYPE
BLA
ORIGINAL APPROVAL
1996-08-23
LATEST ACTION
2026-07-14
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

SEROSTIMPrescription
SOMATROPIN 4MG/VIAL · INJECTABLE · INJECTION
SEROSTIMPrescription
SOMATROPIN 6MG/VIAL · INJECTABLE · INJECTION
SEROSTIMDiscontinued
SOMATROPIN 8.8MG/VIAL · INJECTABLE · INJECTION
SEROSTIMPrescription
SOMATROPIN 5MG/VIAL · INJECTABLE · INJECTION
SEROSTIM LQDiscontinued
SOMATROPIN 6MG/0.5ML (6MG/0.5ML) · INJECTABLE · SUBCUTANEOUS

Approval history

2026-07-14Labeling · Supplement 104 · standard — Letter ↗AP
2017-05-24Labeling · Supplement 74 · standard — Letter ↗AP
2017-05-09Labeling · Supplement 93 · standard — Other ↗AP
2016-12-13Labeling · Supplement 89 · standard — Letter ↗AP
2016-12-13Labeling · Supplement 90 · standard — Letter ↗AP
2014-09-30Manufacturing (CMC) · Supplement 81 · priorityAP
2014-09-17Manufacturing (CMC) · Supplement 80 · priorityAP
2014-08-11Manufacturing (CMC) · Supplement 82 · priorityAP
2014-06-18Labeling · Supplement 78 · unknown — Letter ↗AP
2013-12-12Manufacturing (CMC) · Supplement 76 · priorityAP
2013-12-11Manufacturing (CMC) · Supplement 75 · priorityAP
2013-04-05Manufacturing (CMC) · Supplement 73 · priorityAP
2013-02-28Manufacturing (CMC) · Supplement 71 · priorityAP
2013-02-15Manufacturing (CMC) · Supplement 68 · priorityAP
2013-02-08Manufacturing (CMC) · Supplement 65 · priorityAP
2013-01-31Manufacturing (CMC) · Supplement 67 · priorityAP
2012-11-20Manufacturing (CMC) · Supplement 58 · priorityAP
2012-04-03Labeling · Supplement 49 · standard — Label ↗AP
2009-08-31Labeling · Supplement 48 · standard — Letter ↗AP
2007-08-30Labeling · Supplement 44 · standard — Label ↗AP
2007-07-13Efficacy · Supplement 40 · standard — Review ↗AP
2006-11-27Manufacturing (CMC) · Supplement 35 — Label ↗AP
2006-09-21Manufacturing (CMC) · Supplement 34 · priority — Letter ↗AP
2005-08-24Labeling · Supplement 31 · standard — Label ↗AP
2005-02-11Manufacturing (CMC) · Supplement 29 · priority — Label ↗AP
2004-07-09Manufacturing (CMC) · Supplement 30 · priority — Letter ↗AP
2003-12-01Labeling · Supplement 26 · standard — Review ↗AP
2003-08-29Efficacy · Supplement 27 · standard — Review ↗AP
2002-12-31Manufacturing (CMC) · Supplement 22 · priorityAP
2002-12-20Manufacturing (CMC) · Supplement 21 · priorityAP
2002-10-17Manufacturing (CMC) · Supplement 23 · priorityAP
2002-09-06Manufacturing (CMC) · Supplement 18 · priorityAP
2001-12-03Manufacturing (CMC) · Supplement 20 · priorityAP
2001-11-19Manufacturing (CMC) · Supplement 19 · priorityAP
2001-09-06Labeling · Supplement 16 · standardAP
2001-07-19Manufacturing (CMC) · Supplement 17 · priorityAP
2001-06-13Labeling · Supplement 14 · standardAP
2001-05-03Manufacturing (CMC) · Supplement 15 · priorityAP
2000-10-27Labeling · Supplement 10 · standardAP
2000-09-18Manufacturing (CMC) · Supplement 8 · priorityAP
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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