# HYDROCODONE BITARTRATE AND ACETAMINOPHEN
> **ANDA206245** · Abbreviated New Drug Application (Generic) · Sponsor: NOVEL LABS INC · Approved 2016-12-01
## Drug
- **FDA Application Number:** ANDA206245
- **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:** Discontinued
- **Sponsor:** NOVEL LABS INC
- **Manufacturer:** Lupin Pharmaceuticals,Inc.
- **First approval:** 2016-12-01
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=206245)
---
*AI Analytics · CC0 1.0*