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FDA ANDA · ANDA209116

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA

APPLICATION
ANDA209116
TYPE
ANDA
ORIGINAL APPROVAL
2017-10-30
LATEST ACTION
2017-10-30
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
Over-the-counter

Products

FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDEOver-the-counter
FEXOFENADINE HYDROCHLORIDE 60MG, PSEUDOEPHEDRINE HYDROCHLORIDE 120MG · TABLET, EXTENDED RELEASE · ORAL

Approval history

2017-10-30UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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