← FDA DRUG APPROVALS

FDA NDA · NDA021398

COMBIGAN

brimonidine tartrate, timolol maleate

Sponsor: ABBVIE

APPLICATION
NDA021398
TYPE
NDA
ORIGINAL APPROVAL
2007-10-30
LATEST ACTION
2026-03-17
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

COMBIGAN · ReferencePrescription
BRIMONIDINE TARTRATE 0.2%, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2026-03-17Labeling · Supplement 9 · standard — Letter ↗AP
2015-10-15Labeling · Supplement 7 · standard — Label ↗AP
2012-10-11Labeling · Supplement 6 · standard — Letter ↗AP
2007-10-30Type 4 - New Combination · Original · standard — Review ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Pharma 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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