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FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA · Approved 2017-10-30

Drug application

FDA Application #
ANDA209116
Application type
Abbreviated New Drug Application (Generic)
Brand name
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Generic name
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Active ingredients
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
Over-the-counter
Sponsor
AUROBINDO PHARMA
Manufacturer
Aurohealth LLC
First approval
2017-10-30

Source

Authoritative
Drugs@FDA application overview
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