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LEVOCETIRIZINE DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PADAGIS US · Approved 2011-11-07

Drug application

FDA Application #
ANDA091263
Application type
Abbreviated New Drug Application (Generic)
Brand name
LEVOCETIRIZINE DIHYDROCHLORIDE
Generic name
LEVOCETIRIZINE DIHYDROCHLORIDE
Active ingredients
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription
Sponsor
PADAGIS US
Manufacturer
Padagis Israel Pharmaceuticals Ltd
First approval
2011-11-07

Source

Authoritative
Drugs@FDA application overview
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