General MedicationsORALStandard
TAPENTADOL HYDROCHLORIDE
TAPENTADOL HYDROCHLORIDE
Standard Dose
EQ 100MG BASE
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview TAPENTADOL HYDROCHLORIDE is listed in Drugs@FDA under application 214378 (ANDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient TAPENTADOL HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor HUMANWELL Submission history Latest submission status date: 2026-01-27 00:00:00.
Structured Monograph
Clinical summary
Approval overview TAPENTADOL HYDROCHLORIDE is listed in Drugs@FDA under application 214378 (ANDA). Review priority: STANDARD Marketing status: Prescription Active ingredient TAPENTADOL HYDROCHLORIDE Form and strength TABLET;ORAL - EQ 100MG BASE Sponsor HUMANWELL Submission history Latest submission status date: 2026-01-27 00:00:00. Submission type: ORIG.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.