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PROMETHAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS · Approved 2009-12-30

Drug application

FDA Application #

ANDA040882

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROMETHAZINE HYDROCHLORIDE

Generic name

Promethazine Hydrochloride

Active ingredients

PROMETHAZINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Discontinued

Sponsor

AMNEAL PHARMS

First approval

2009-12-30

Source

Authoritative

Drugs@FDA application overview

Machine

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