← FDA DRUG APPROVALS

FDA BLA · BLA021629

APIDRA

insulin glulisine

Sponsor: SANOFI AVENTIS US

APPLICATION
BLA021629
TYPE
BLA
ORIGINAL APPROVAL
2004-04-16
LATEST ACTION
2022-11-30
ROUTE
INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS, SUBCUTANEOUS
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription, Discontinued

Products

APIDRA SOLOSTARPrescription
INSULIN GLULISINE RECOMBINANT 300 UNITS/3ML · INJECTABLE · SUBCUTANEOUS
APIDRAPrescription
INSULIN GLULISINE RECOMBINANT 1000 UNITS/10ML (100 UNITS/ML) · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS
APIDRADiscontinued
INSULIN GLULISINE RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) · INJECTABLE · INTRAVENOUS, SUBCUTANEOUS

Approval history

2022-11-30Labeling · Supplement 42 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 40 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 39 · standard — Letter ↗AP
2018-12-20Labeling · Supplement 37 · standard — Label ↗AP
2018-12-20Labeling · Supplement 38 · standard — Label ↗AP
2015-03-03Manufacturing (CMC) · Supplement 31 · standardAP
2015-02-25Labeling · Supplement 30 · 901 required — Letter ↗AP
2014-05-14Labeling · Supplement 29 · standard — Label ↗AP
2013-09-06Labeling · Supplement 28 · standard — Letter ↗AP
2013-07-22Manufacturing (CMC) · Supplement 24 · standardAP
2013-06-05Manufacturing (CMC) · Supplement 26 · standardAP
2013-02-15Manufacturing (CMC) · Supplement 27 · standardAP
2009-02-24Manufacturing (CMC) · Supplement 8 — Letter ↗AP
2008-10-24Efficacy · Supplement 15 · unknown — Label ↗AP
2007-04-12Efficacy · Supplement 10 · unknown — Letter ↗AP
2005-12-20Labeling · Supplement 1 · standard — Label ↗AP
2005-12-20Manufacturing (CMC) · Supplement 2 · standard — Label ↗AP
2004-04-16Type 1 - New Molecular Entity · Original · standard — Label ↗AP
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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