FDA BLA · BLA019764

SAIZEN

Sponsor: EMD SERONO

APPLICATION

BLA019764

TYPE

BLA

ORIGINAL APPROVAL

1996-10-08

LATEST ACTION

2017-05-08

ROUTE

INJECTION

DOSAGE FORM

INJECTABLE

MARKETING STATUS

Prescription, Discontinued

Products

SAIZENPrescription

SOMATROPIN 5MG/VIAL · INJECTABLE · INJECTION

SAIZENDiscontinued

SOMATROPIN 4MG/VIAL · INJECTABLE · INJECTION

SAIZENPrescription

SOMATROPIN 8.8MG/VIAL · INJECTABLE · INJECTION

SAIZENDiscontinued

SOMATROPIN 6MG/VIAL · INJECTABLE · INJECTION

Approval history

2017-05-08Labeling · Supplement 86 · standard — Label ↗AP

2017-01-17Manufacturing (CMC) · Supplement 79 · standard — Label ↗AP

2016-12-13Labeling · Supplement 83 · standard — Letter ↗AP

2016-04-21Manufacturing (CMC) · Supplement 80 · standard — Other ↗AP

2015-06-12Manufacturing (CMC) · Supplement 78 · standardAP

2015-06-11Manufacturing (CMC) · Supplement 62 · standardAP

2015-03-03Manufacturing (CMC) · Supplement 77 · standardAP

2015-02-16Manufacturing (CMC) · Supplement 76 · standardAP

2014-09-30Manufacturing (CMC) · Supplement 73 · standardAP

2014-08-11Manufacturing (CMC) · Supplement 74 · standardAP

2014-06-18Labeling · Supplement 72 · unknown — Letter ↗AP

2013-12-12Manufacturing (CMC) · Supplement 70 · standardAP

2013-11-18Manufacturing (CMC) · Supplement 71 · standardAP

2013-11-13Manufacturing (CMC) · Supplement 59 · standardAP

2013-04-05Manufacturing (CMC) · Supplement 69 · standardAP

2013-02-20Manufacturing (CMC) · Supplement 67 · standardAP

2013-02-15Manufacturing (CMC) · Supplement 65 · standardAP

2013-02-15Manufacturing (CMC) · Supplement 66 · standardAP

2013-02-13Manufacturing (CMC) · Supplement 63 · standardAP

2013-02-08Manufacturing (CMC) · Supplement 61 · standardAP

2013-02-07Manufacturing (CMC) · Supplement 60 · standardAP

2013-01-31Manufacturing (CMC) · Supplement 64 · standardAP

2013-01-19Manufacturing (CMC) · Supplement 57 · standardAP

2013-01-19Manufacturing (CMC) · Supplement 58 · standardAP

2013-01-19Manufacturing (CMC) · Supplement 56 · standardAP

2013-01-18Manufacturing (CMC) · Supplement 54 · standardAP

2013-01-11Manufacturing (CMC) · Supplement 53 · standardAP

2013-01-11Manufacturing (CMC) · Supplement 52 · standardAP

2012-04-03Labeling · Supplement 49 · unknown — Letter ↗AP

2007-10-31Manufacturing (CMC) · Supplement 35 — Label ↗AP

2007-08-27Labeling · Supplement 39 · standard — Letter ↗AP

2007-08-22Labeling · Supplement 37 · standard — Letter ↗AP

2007-03-05Labeling · Supplement 34 · standard — Label ↗AP

2007-01-16Manufacturing (CMC) · Supplement 30 — Label ↗AP

2004-11-01Efficacy · Supplement 20 · standard — Label ↗AP

2004-07-09Manufacturing (CMC) · Supplement 25 · standard — Letter ↗AP

2003-07-01Labeling · Supplement 23 · standard — Letter ↗AP

2002-12-31Manufacturing (CMC) · Supplement 18 · standardAP

2002-12-20Manufacturing (CMC) · Supplement 17 · standardAP

2002-10-17Manufacturing (CMC) · Supplement 19 · standardAP

VIEW ON DRUGS@FDA ↗

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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →

SAIZEN

Products

Approval history

Related on SPEQ

Get the Weekly GxP Briefing