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TAPENTADOL

ANDA · Abbreviated New Drug Application (Generic) · Sponsor: WEST-WARD PHARMS INT · Approved 2026-02-13

Drug application

FDA Application #
ANDA206418
Application type
Abbreviated New Drug Application (Generic)
Brand name
TAPENTADOL
Generic name
Tapentadol
Active ingredients
TAPENTADOL
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Marketing status
None (Tentative Approval)
Sponsor
WEST-WARD PHARMS INT
First approval
2026-02-13

Source

Authoritative
Drugs@FDA application overview
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