← FDA Drug Approvals (Drugs@FDA)

OMEPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HETERO LABS LTD III · Approved 2019-09-26

Drug application

FDA Application #

ANDA204012

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEPRAZOLE

Generic name

OMEPRAZOLE

Active ingredients

OMEPRAZOLE

Dosage form

CAPSULE, DELAYED REL PELLETS

Route

ORAL

Marketing status

Prescription

Sponsor

HETERO LABS LTD III

Manufacturer

Camber Pharmaceuticals, Inc.

First approval

2019-09-26

Source

Authoritative

Drugs@FDA application overview

Machine

JSON-LD · Markdown