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LEVOCETIRIZINE DIHYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: APOTEX INC · Approved 2018-11-02

Drug application

FDA Application #

ANDA211528

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

None (Tentative Approval)

Sponsor

APOTEX INC

First approval

2018-11-02

Source

Authoritative

Drugs@FDA application overview

Machine

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