# HYDROCODONE BITARTRATE AND IBUPROFEN
> **ANDA076604** · Abbreviated New Drug Application (Generic) · Sponsor: ACTAVIS LABS FL INC · Approved 2003-12-31
## Drug
- **FDA Application Number:** ANDA076604
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** HYDROCODONE BITARTRATE AND IBUPROFEN
- **Generic name:** Hydrocodone Bitartrate
- **Active ingredients:** HYDROCODONE BITARTRATE; IBUPROFEN
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** ACTAVIS LABS FL INC
- **First approval:** 2003-12-31
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=076604)
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