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HYDROCODONE BITARTRATE AND IBUPROFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AMNEAL PHARMS NY · Approved 2004-03-18

Drug application

FDA Application #

ANDA076642

Application type

Abbreviated New Drug Application (Generic)

Brand name

HYDROCODONE BITARTRATE AND IBUPROFEN

Generic name

HYDROCODONE BITARTRATE AND IBUPROFEN

Active ingredients

HYDROCODONE BITARTRATE; IBUPROFEN

Dosage form

TABLET

Route

ORAL

Marketing status

Prescription

Sponsor

AMNEAL PHARMS NY

Manufacturer

Amneal Pharmaceuticals of New York LLC

First approval

2004-03-18

Source

Authoritative

Drugs@FDA application overview

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