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HYDROCODONE BITARTRATE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: TRIS PHARMA INC · Approved 2013-03-27

Drug application

FDA Application #
ANDA202214
Application type
Abbreviated New Drug Application (Generic)
Brand name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Generic name
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Active ingredients
ACETAMINOPHEN; HYDROCODONE BITARTRATE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
TRIS PHARMA INC
Manufacturer
Cranbury Pharmaceuticals, LLC
First approval
2013-03-27

Source

Authoritative
Drugs@FDA application overview
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