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HYDROCODONE BITARTRATE AND IBUPROFEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: AUROLIFE PHARMA LLC · Approved 2016-06-02

Drug application

FDA Application #
ANDA204575
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
AUROLIFE PHARMA LLC
Manufacturer
Aurolife Pharma, LLC
First approval
2016-06-02

Source

Authoritative
Drugs@FDA application overview
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