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FDA ANDA · ANDA205057

TAPENTADOL HYDROCHLORIDE

Sponsor: HIKMA

APPLICATION
ANDA205057
TYPE
ANDA
ORIGINAL APPROVAL
2026-02-10
LATEST ACTION
2026-06-18
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TAPENTADOL HYDROCHLORIDEDiscontinued
TAPENTADOL HYDROCHLORIDE EQ 100MG BASE · TABLET · ORAL
TAPENTADOL HYDROCHLORIDEDiscontinued
TAPENTADOL HYDROCHLORIDE EQ 50MG BASE · TABLET · ORAL
TAPENTADOL HYDROCHLORIDEDiscontinued
TAPENTADOL HYDROCHLORIDE EQ 75MG BASE · TABLET · ORAL

Approval history

2026-06-18REMS · Supplement 3AP
2026-02-10UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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