# HYDROCODONE BITARTRATE AND ACETAMINOPHEN
> **ANDA040881** · Abbreviated New Drug Application (Generic) · Sponsor: MIKART · Approved 2010-02-25
## Drug
- **FDA Application Number:** ANDA040881
- **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:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** MIKART
- **Manufacturer:** Hikma Pharmaceuticals USA Inc.
- **First approval:** 2010-02-25
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=040881)
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