← FDA DRUG APPROVALS

FDA BLA · BLA021081

LANTUS SOLOSTAR

insulin glargine

Sponsor: SANOFI AVENTIS US

APPLICATION
BLA021081
TYPE
BLA
ORIGINAL APPROVAL
2000-04-20
LATEST ACTION
2023-06-29
ROUTE
SUBCUTANEOUS, INJECTION
DOSAGE FORM
INJECTABLE
MARKETING STATUS
Prescription

Products

LANTUS SOLOSTARPrescription
INSULIN GLARGINE RECOMBINANT 300 UNITS/3ML (100 UNITS/ML) · INJECTABLE · INJECTION
LANTUSPrescription
INSULIN GLARGINE RECOMBINANT 100 UNITS/ML · INJECTABLE · INJECTION

Approval history

2023-06-29Labeling · Supplement 78 · standard — Label ↗AP
2023-06-29Labeling · Supplement 79 · standard — Label ↗AP
2022-06-07Labeling · Supplement 76 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 74 · standard — Letter ↗AP
2019-11-15Labeling · Supplement 73 · standard — Label ↗AP
2019-05-09Labeling · Supplement 72 · standard — Letter ↗AP
2018-11-29Labeling · Supplement 71 · standard — Letter ↗AP
2016-04-13Manufacturing (CMC) · Supplement 65 · standardAP
2015-07-17Efficacy · Supplement 63 · standard — Letter ↗AP
2015-06-16Manufacturing (CMC) · Supplement 64 · standardAP
2015-02-25Labeling · Supplement 62 · 901 required — Review ↗AP
2014-09-05Manufacturing (CMC) · Supplement 61 · standardAP
2013-10-18Efficacy · Supplement 57 · standard — Label ↗AP
2013-08-14Manufacturing (CMC) · Supplement 49 · standardAP
2013-07-18Manufacturing (CMC) · Supplement 58 · standardAP
2013-06-05Manufacturing (CMC) · Supplement 59 · standardAP
2013-05-16Labeling · Supplement 55 · standard — Label ↗AP
2013-03-27Manufacturing (CMC) · Supplement 56 · standardAP
2009-09-09Efficacy · Supplement 34 · unknown — Label ↗AP
2007-04-25Manufacturing (CMC) · Supplement 24 — Letter ↗AP
2005-03-15Manufacturing (CMC) · Supplement 17 · standard — Review ↗AP
2005-02-11Manufacturing (CMC) · Supplement 14 · standard — Letter ↗AP
2004-08-10Manufacturing (CMC) · Supplement 11 · standard — Letter ↗AP
2003-05-01Efficacy · Supplement 5 · standard — Label ↗AP
2002-08-15Manufacturing (CMC) · Supplement 4 · standardAP
2001-03-07Manufacturing (CMC) · Supplement 2 · standardAP
2001-01-31Manufacturing (CMC) · Supplement 3 · standardAP
2000-11-17Manufacturing (CMC) · Supplement 1 · standardAP
2000-04-20Type 1 - New Molecular Entity · 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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