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FDA ANDA · ANDA203058

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

Sponsor: EPIC PHARMA LLC

APPLICATION
ANDA203058
TYPE
ANDA
ORIGINAL APPROVAL
2014-09-22
LATEST ACTION
2025-02-11
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

2025-02-11Labeling · Supplement 3 · standardAP
2023-03-08Labeling · Supplement 1 · standardAP
2023-03-08Labeling · Supplement 2 · standardAP
2014-09-22UNKNOWN · Original — Label ↗AP
VIEW ON DRUGS@FDA ↗

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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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