← FDA DRUG APPROVALS

FDA NDA · NDA202667

COSOPT PF

dorzolamide hydrochloride and timolol maleate

Sponsor: THEA PHARMA

APPLICATION
NDA202667
TYPE
NDA
ORIGINAL APPROVAL
2012-02-01
LATEST ACTION
2026-04-09
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

COSOPT PF · ReferencePrescription
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2026-04-09Labeling · Supplement 5 · standard — Letter ↗AP
2012-02-01Type 5 - New Formulation or New Manufacturer · Original · standard — Letter ↗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.

Weekly Briefing

Get the Weekly GxP Briefing

Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.

Read a past issue →