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FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2015-01-29

Drug application

FDA Application #
ANDA090818
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
SUN PHARM
Manufacturer
AmeriSource Bergen
First approval
2015-01-29

Source

Authoritative
Drugs@FDA application overview
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