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FDA NDA · NDA022184

LUMIGAN

bimatoprost

Sponsor: ABBVIE

APPLICATION
NDA022184
TYPE
NDA
ORIGINAL APPROVAL
2010-08-31
LATEST ACTION
2022-03-08
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

LUMIGAN · ReferencePrescription
BIMATOPROST 0.01% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2022-03-08Labeling · Supplement 9 · standard — Letter ↗AP
2020-09-29Labeling · Supplement 8 · standard — Letter ↗AP
2017-07-29Labeling · Supplement 6 · standard — Label ↗AP
2014-09-29Labeling · Supplement 5 · standard — Label ↗AP
2014-09-19Manufacturing (CMC) · Supplement 3 · standardAP
2013-07-22Manufacturing (CMC) · Supplement 2 · standardAP
2012-03-15Labeling · Supplement 1 · unknown — Label ↗AP
2010-08-31Type 5 - New Formulation or New Manufacturer · Original · standard — Summary 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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