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PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: QUAGEN · Approved 2020-10-08

Drug application

FDA Application #

ANDA214238

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Generic name

PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE

Active ingredients

CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Prescription

Sponsor

QUAGEN

Manufacturer

QUAGEN PHARMACEUTICALS LLC

First approval

2020-10-08

Source

Authoritative

Drugs@FDA application overview

Machine

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