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LEVOCETIRIZINE DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2020-04-29

Drug application

FDA Application #
ANDA213513
Application type
Abbreviated New Drug Application (Generic)
Brand name
LEVOCETIRIZINE DIHYDROCHLORIDE
Generic name
LEVOCETIRIZINE DIHYDROCHLORIDE 5 MG
Active ingredients
LEVOCETIRIZINE DIHYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Over-the-counter
Sponsor
HETERO LABS LTD III
Manufacturer
Little Pharma, Inc.
First approval
2020-04-29

Source

Authoritative
Drugs@FDA application overview
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