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FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PLD ACQUISITIONS LLC · Approved 2010-02-25

Drug application

FDA Application #
ANDA077999
Application type
Abbreviated New Drug Application (Generic)
Brand name
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Generic name
Fexofenadine Hydrochloride
Active ingredients
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
PLD ACQUISITIONS LLC
First approval
2010-02-25

Source

Authoritative
Drugs@FDA application overview
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