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PROMETHAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: COSETTE · Approved 2012-06-28

Drug application

FDA Application #

ANDA091675

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

Prescription

Sponsor

COSETTE

Manufacturer

Cranbury Pharmaceuticals, LLC

First approval

2012-06-28

Source

Authoritative

Drugs@FDA application overview

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