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OXYCODONE AND ACETAMINOPHEN

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: MIKART · Approved 2018-11-27

Drug application

FDA Application #
ANDA202142
Application type
Abbreviated New Drug Application (Generic)
Brand name
OXYCODONE AND ACETAMINOPHEN
Generic name
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
Active ingredients
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
Dosage form
SOLUTION
Route
ORAL
Marketing status
Prescription
Sponsor
MIKART
Manufacturer
Forte Bio-Pharma LLC
First approval
2018-11-27

Source

Authoritative
Drugs@FDA application overview
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