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PROMETH PLAIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS MID ATLANTIC · Approved 1978-08-21

Drug application

FDA Application #

ANDA085953

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROMETH PLAIN

Generic name

Promethazine Hydrochloride

Active ingredients

PROMETHAZINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Discontinued

Sponsor

ACTAVIS MID ATLANTIC

First approval

1978-08-21

Source

Authoritative

Drugs@FDA application overview

Machine

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