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FDA ANDA · ANDA211830

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Sponsor: COREPHARMA

APPLICATION
ANDA211830
TYPE
ANDA
ORIGINAL APPROVAL
2019-08-22
LATEST ACTION
2019-08-22
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Over-the-counter

Products

NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDEOver-the-counter
DIPHENHYDRAMINE HYDROCHLORIDE 25MG, NAPROXEN SODIUM 220MG · TABLET · ORAL

Approval history

2019-08-22UNKNOWN · Original · standard — Letter ↗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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