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FDA NDA · NDA021275

LUMIGAN

Sponsor: ABBVIE

APPLICATION
NDA021275
TYPE
NDA
ORIGINAL APPROVAL
2001-03-16
LATEST ACTION
2022-03-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Discontinued

Products

LUMIGAN · ReferenceDiscontinued
BIMATOPROST 0.03% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-03-08Labeling · Supplement 29 · standard — Letter ↗AP
2020-10-15Labeling · Supplement 28 · standard — Letter ↗AP
2017-07-29Labeling · Supplement 27 · standard — Label ↗AP
2014-09-29Labeling · Supplement 26 · standard — Label ↗AP
2013-02-28Manufacturing (CMC) · Supplement 24 · priorityAP
2012-03-15Labeling · Supplement 23 · unknown — Letter ↗AP
2011-03-11Labeling · Supplement 11 · standard — Label ↗AP
2011-03-11Labeling · Supplement 22 · unknown — Label ↗AP
2006-06-22Efficacy · Supplement 13 · unknown — Review ↗AP
2003-11-10Manufacturing (CMC) · Supplement 14 · priority — Letter ↗AP
2003-11-10Labeling · Supplement 15 · standard — Letter ↗AP
2003-08-25Labeling · Supplement 12 · standard — Letter ↗AP
2003-08-25Manufacturing (CMC) · Supplement 10 · priority — Label ↗AP
2002-08-26Labeling · Supplement 6 · standard — Label ↗AP
2002-04-17Manufacturing (CMC) · Supplement 3 · priorityAP
2002-04-12Manufacturing (CMC) · Supplement 5 · priorityAP
2001-08-07Manufacturing (CMC) · Supplement 2 · priorityAP
2001-03-16Type 1 - New Molecular Entity · Original · priority — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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