Other opioids

Tapentadol

Approved 31 Mar 2016OralTablet

The FDA lists this product in 13 strengths and forms.

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Composition

Active ingredients: TAPENTADOL 75MG

Strengths and forms

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TAPENTADOL 100MG · Tablet, extended releaseANDA204972-002 · Tentative approval

TAPENTADOL 250MG · Tablet, extended releaseANDA204972-005 · Tentative approval

Official product information

Drugs@FDA lists the approved labels, letters and reviews for application ANDA205015.

Open Drugs@FDA

Prognia shows this product information for reference and learning. It is not treatment advice and can lag behind the official text. Always check the current product information and local protocols before prescribing.

At a glance

Brand name: Tapentadol
Drug class: Other opioids
Group: Opioids
Route: Oral
Dosage form: Tablet
Applicant: Alkem Labs LTD
Status: Tentative approval
FDA approval: 31 Mar 2016
Application: ANDA205015-002
RxCUI: 787390

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