# TAPENTADOL HYDROCHLORIDE
> **ANDA205057** · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2026-02-10
## Drug
- **FDA Application Number:** ANDA205057
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TAPENTADOL HYDROCHLORIDE
- **Generic name:** Tapentadol Hydrochloride
- **Active ingredients:** TAPENTADOL HYDROCHLORIDE
- **Dosage form:** TABLET
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** HIKMA
- **First approval:** 2026-02-10
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=205057)
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