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PROMETHAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: CHARTWELL RX · Approved 1998-09-25

Drug application

FDA Application #

ANDA040026

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

CHARTWELL RX

Manufacturer

Chartwell Governmental & Specialty RX, LLC.

First approval

1998-09-25

Source

Authoritative

Drugs@FDA application overview

Machine

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