← FDA Drug Approvals (Drugs@FDA)
OXYCODONE AND ACETAMINOPHEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: ELITE LABS INC · Approved 2018-07-02
Drug application
- FDA Application #
ANDA209385- 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
- TABLET
- Route
- ORAL
- Marketing status
- Prescription
- Sponsor
- ELITE LABS INC
- Manufacturer
- Elite Laboratories, Inc.
- First approval
- 2018-07-02
Source
- Authoritative
- Drugs@FDA application overview
- Machine
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