FDA
Tapentadol Hydrochloride
The FDA lists this product in 10 strengths and forms.
Composition
- Active ingredients
- TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
- TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML · SolutionANDA206657-001 · Tentative approval
- TAPENTADOL HYDROCHLORIDE 100MG · TabletANDA209369-003 · Tentative approval
- TAPENTADOL HYDROCHLORIDE 75MG · TabletANDA209369-002 · Tentative approval
- TAPENTADOL HYDROCHLORIDE EQ 100MG BASE · TabletANDA205057-003 · Prescription
- TAPENTADOL HYDROCHLORIDE EQ 50MG BASE · TabletANDA205057-001 · Prescription
- TAPENTADOL HYDROCHLORIDE EQ 75MG BASE · TabletANDA205057-002 · Prescription
- TAPENTADOL HYDROCHLORIDE EQ 20MG BASE/ML · SolutionThis page
- TAPENTADOL HYDROCHLORIDE EQ 75MG BASE · TabletANDA214378-002 · Prescription
- TAPENTADOL HYDROCHLORIDE EQ 100MG BASE · TabletANDA214378-003 · Prescription
- TAPENTADOL HYDROCHLORIDE EQ 50MG BASE · TabletANDA214378-001 · Prescription
At a glance
- Brand name
- Tapentadol Hydrochloride
- Route
- Oral
- Dosage form
- Solution
- Applicant
- Novitium Pharma
- Status
- Prescription
- FDA approval
- 26 Jan 2026
- Application
- ANDA219119-001