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FDA ANDA · ANDA079115

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: WOCKHARDT

APPLICATION
ANDA079115
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)

Products

FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDENone (Tentative Approval)
FEXOFENADINE HYDROCHLORIDE 60MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2010-10-19OriginalTA
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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