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FDA ANDA · ANDA215936

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE

dorzolamide hydrochloride and timolol maleate preservative free

Sponsor: MICRO LABS

APPLICATION
ANDA215936
TYPE
ANDA
ORIGINAL APPROVAL
2022-01-25
LATEST ACTION
2024-07-18
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

2024-07-18Labeling · Supplement 3 · standardAP
2022-01-25UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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