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OXYCODONE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2017-02-24

Drug application

FDA Application #
ANDA204407
Application type
Abbreviated New Drug Application (Generic)
Brand name
OXYCODONE AND ACETAMINOPHEN
Generic name
OXYCODONE AND ACETAMINOPHEN
Active ingredients
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage form
TABLET
Route
ORAL
Marketing status
Prescription
Sponsor
NOVEL LABS INC
Manufacturer
Lupin Pharmaceuticals,Inc.
First approval
2017-02-24

Source

Authoritative
Drugs@FDA application overview
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