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FDA ANDA · ANDA207630

DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE PRESERVATIVE FREE

Sponsor: EUGIA PHARMA

APPLICATION
ANDA207630
TYPE
ANDA
ORIGINAL APPROVAL
2018-07-24
LATEST ACTION
2023-06-02
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

2023-06-02Manufacturing (CMC) · Supplement 1 · unknownAP
2018-07-24UNKNOWN · Original · standard — Letter ↗AP
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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