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HYDROCODONE BITARTRATE AND IBUPROFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2003-12-31

Drug application

FDA Application #
ANDA076604
Application type
Abbreviated New Drug Application (Generic)
Brand name
HYDROCODONE BITARTRATE AND IBUPROFEN
Generic name
Hydrocodone Bitartrate
Active ingredients
HYDROCODONE BITARTRATE; IBUPROFEN
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
ACTAVIS LABS FL INC
First approval
2003-12-31

Source

Authoritative
Drugs@FDA application overview
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