# HYDROCODONE BITARTRATE AND ACETAMINOPHEN
> **ANDA211729** · Abbreviated New Drug Application (Generic) · Sponsor: GRANULES · Approved 2020-01-03
## Drug
- **FDA Application Number:** 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
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=211729)
---
*MORVS · CC0 1.0*