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OMEPRAZOLE MAGNESIUM

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SPIL · Approved 2018-07-20

Drug application

FDA Application #

ANDA210593

Application type

Abbreviated New Drug Application (Generic)

Brand name

OMEPRAZOLE MAGNESIUM

Generic name

OMEPRAZOLE

Active ingredients

OMEPRAZOLE MAGNESIUM

Dosage form

CAPSULE, DELAYED RELEASE

Route

ORAL

Marketing status

Discontinued

Sponsor

SPIL

Manufacturer

INNOVUS PHARMACEUTICALS, INC.

First approval

2018-07-20

Source

Authoritative

Drugs@FDA application overview

Machine

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