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OMEPRAZOLE

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SUN PHARM · Approved 2018-10-12

Drug application

FDA Application #

ANDA207891

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEPRAZOLE

Generic name

OMEPRAZOLE

Active ingredients

OMEPRAZOLE

Dosage form

TABLET, DELAYED RELEASE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

SUN PHARM

Manufacturer

OHM LABORATORIES INC.

First approval

2018-10-12

Source

Authoritative

Drugs@FDA application overview

Machine

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