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IBUPROFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: SOFGEN PHARMS · Approved 2016-09-07

Drug application

FDA Application #

ANDA203599

Application type

Abbreviated New Drug Application (Generic)

Brand name

IBUPROFEN

Generic name

IBUPROFEN

Active ingredients

IBUPROFEN

Dosage form

CAPSULE

Route

ORAL

Marketing status

Over-the-counter

Sponsor

SOFGEN PHARMS

Manufacturer

Topco Associates LLC

First approval

2016-09-07

Source

Authoritative

Drugs@FDA application overview

Machine

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