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FDA ANDA · ANDA211360

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE COLD AND SINUS

naproxen sodium and pseudoephedrine hydrochloride

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA211360
TYPE
ANDA
ORIGINAL APPROVAL
2022-06-01
LATEST ACTION
2022-06-01
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
NAPROXEN SODIUM 220MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2022-06-01UNKNOWN · 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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