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FEXOFENADINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROBINDO PHARMA LTD · Approved 2023-05-23

Drug application

FDA Application #
ANDA213466
Application type
Abbreviated New Drug Application (Generic)
Brand name
FEXOFENADINE HYDROCHLORIDE
Generic name
FEXOFENADINE HYDROCHLORIDE ORAL
Active ingredients
FEXOFENADINE HYDROCHLORIDE
Dosage form
SUSPENSION
Route
ORAL
Marketing status
Over-the-counter
Sponsor
AUROBINDO PHARMA LTD
Manufacturer
Aurohealth LLC
First approval
2023-05-23

Source

Authoritative
Drugs@FDA application overview
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