← FDA DRUG APPROVALS

FDA ANDA · ANDA217260

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Sponsor: INGENUS PHARMS LLC

APPLICATION
ANDA217260
TYPE
ANDA
ORIGINAL APPROVAL
2023-05-01
LATEST ACTION
2023-05-01
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Prescription

Products

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATEPrescription
DORZOLAMIDE HYDROCHLORIDE EQ 2% BASE, TIMOLOL MALEATE EQ 0.5% BASE · SOLUTION/DROPS · OPHTHALMIC

Approval history

2023-05-01UNKNOWN · Original · standardAP
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 →