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ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2016-09-27
Drug application
- FDA Application #
ANDA207113- Application type
- Abbreviated New Drug Application (Generic)
- Brand name
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Generic name
- Acetaminophen
- Active ingredients
- ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
- Dosage form
- TABLET, EXTENDED RELEASE
- Route
- ORAL
- Marketing status
- None (Tentative Approval)
- Sponsor
- ACTAVIS LABS FL INC
- First approval
- 2016-09-27
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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