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IBUPROFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES INDIA · Approved 2010-12-10

Drug application

FDA Application #

ANDA079174

Application type

Abbreviated New Drug Application (Generic)

Brand name

IBUPROFEN

Generic name

IBUPROFEN

Active ingredients

IBUPROFEN

Dosage form

TABLET

Route

ORAL

Marketing status

Over-the-counter

Sponsor

GRANULES INDIA

Manufacturer

Dolgencorp, Inc.

First approval

2010-12-10

Source

Authoritative

Drugs@FDA application overview

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