← FDA Drug Approvals (Drugs@FDA)
TAPENTADOL HYDROCHLORIDE
ANDA · Abbreviated New Drug Application (Generic) · Sponsor: HIKMA · Approved 2026-02-10
Drug application
- FDA Application #
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
- Authoritative
- Drugs@FDA application overview
- Machine
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