# TRAMADOL HYDROCHLORIDE
> **ANDA219647** · Abbreviated New Drug Application (Generic) · Sponsor: NOVITIUM PHARMA · Approved 2026-06-26
## Drug
- **FDA Application Number:** ANDA219647
- **Application type:** Abbreviated New Drug Application (Generic)
- **Brand name:** TRAMADOL HYDROCHLORIDE
- **Generic name:** Tramadol Hydrochloride
- **Active ingredients:** TRAMADOL HYDROCHLORIDE
- **Dosage form:** SOLUTION
- **Route:** ORAL
- **Marketing status:** Prescription
- **Sponsor:** NOVITIUM PHARMA
- **First approval:** 2026-06-26
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=219647)
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