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FDA ANDA · ANDA215232

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD

APPLICATION
ANDA215232
TYPE
ANDA
ORIGINAL APPROVAL
2025-04-17
LATEST ACTION
2025-04-17
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
FEXOFENADINE HYDROCHLORIDE 180MG, PSEUDOEPHEDRINE HYDROCHLORIDE 240MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2025-04-17UNKNOWN · 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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