FDA NDA · NDA022369

LATISSE

bimatoprost

Sponsor: ABBVIE

APPLICATION

NDA022369

TYPE

NDA

ORIGINAL APPROVAL

2008-12-24

LATEST ACTION

2021-08-26

ROUTE

OPHTHALMIC, TOPICAL

DOSAGE FORM

SOLUTION/DROPS

MARKETING STATUS

Prescription

Products

LATISSE · ReferencePrescription

BIMATOPROST 0.03% · SOLUTION/DROPS · TOPICAL

2021-08-26Labeling · Supplement 14 · standard — Letter ↗AP

2020-09-29Labeling · Supplement 12 · standard — Letter ↗AP

2017-07-29Labeling · Supplement 11 · standard — Label ↗AP

2014-09-04Efficacy · Supplement 10 · priority — Pediatric DD Summary Review ↗AP

2014-09-04Labeling · Supplement 8 · standard — Pediatric DD Summary Review ↗AP

2013-11-01Manufacturing (CMC) · Supplement 9 · priorityAP

2013-03-13Manufacturing (CMC) · Supplement 7 · priority — Label ↗AP

2013-01-31Manufacturing (CMC) · Supplement 6 · priorityAP

2012-03-29Manufacturing (CMC) · Supplement 5 · priority — Label ↗AP

2011-09-07Manufacturing (CMC) · Supplement 3 · priorityAP

2011-09-07Labeling · Supplement 4 · unknown — Letter ↗AP

2008-12-24Type 5 - New Formulation or New Manufacturer · Original · priority — Label ↗AP

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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