← FDA Drug Approvals (Drugs@FDA)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2020-01-03
Drug application
- FDA Application #
ANDA211729
- 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
- GRANULES
- Manufacturer
- Granules Pharmaceuticals Inc.
- First approval
- 2020-01-03
Source
- Authoritative
- Drugs@FDA application overview
- Machine
- JSON-LD · Markdown