← FDA Drug Approvals (Drugs@FDA)

PROMETHAZINE PLAIN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: PHARMOBEDIENT · Approved 1982-11-15

Drug application

FDA Application #

ANDA087953

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROMETHAZINE PLAIN

Generic name

PROMETHAZINE HYDROCHLORIDE

Active ingredients

PROMETHAZINE HYDROCHLORIDE

Dosage form

SYRUP

Route

ORAL

Marketing status

Prescription

Sponsor

PHARMOBEDIENT

Manufacturer

Xttrium Laboratories, Inc.

First approval

1982-11-15

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown