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CETIRIZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL MOLECULAR · Approved 2012-05-11

Drug application

FDA Application #
ANDA078876
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
CHARTWELL MOLECULAR
Manufacturer
Heritage Pharma Labs Inc. d/b/a Avet Pharmaceuticals Labs Inc.
First approval
2012-05-11

Source

Authoritative
Drugs@FDA application overview
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