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FDA ANDA · ANDA078208

NAPHAZOLINE HCI AND PHENIRAMINE MALEATE

naphazoline hydrochloride , pheniramine maleate

Sponsor: ALTAIRE PHARMS INC

APPLICATION
ANDA078208
TYPE
ANDA
ORIGINAL APPROVAL
2010-09-27
LATEST ACTION
2010-09-27
ROUTE
OPHTHALMIC
DOSAGE FORM
SOLUTION/DROPS
MARKETING STATUS
Over-the-counter

Products

NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATEOver-the-counter
NAPHAZOLINE HYDROCHLORIDE 0.02675%, PHENIRAMINE MALEATE 0.315% · SOLUTION/DROPS · OPHTHALMIC

Approval history

2010-09-27Original — Review ↗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.

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