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CETIRIZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARM ASSOC · Approved 2008-06-18

Drug application

FDA Application #
ANDA078412
Application type
Abbreviated New Drug Application (Generic)
Brand name
CETIRIZINE HYDROCHLORIDE
Generic name
CETIRIZINE HYDROCHLORIDE
Active ingredients
CETIRIZINE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription
Sponsor
PHARM ASSOC
Manufacturer
PAI Holdings, LLC dba PAI Pharma
First approval
2008-06-18

Source

Authoritative
Drugs@FDA application overview
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