← FDA Drug Approvals (Drugs@FDA)

PROMETHAZINE HYDROCHLORIDE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS NY · Approved 2010-12-13

Drug application

FDA Application #

ANDA091179

Application type

Abbreviated New Drug Application (Generic)

Brand name

PROMETHAZINE HYDROCHLORIDE

Generic name

PROMETHAZINE HYDROCHLORIDE

Active ingredients

PROMETHAZINE HYDROCHLORIDE

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL PHARMS NY

Manufacturer

Amneal Pharmaceuticals LLC

First approval

2010-12-13

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown