APPLICATION
ANDA206418
TYPE
ANDA
ROUTE
ORAL
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
TAPENTADOLNone (Tentative Approval)
TAPENTADOL 200MG · TABLET, EXTENDED RELEASE · ORAL
TAPENTADOLNone (Tentative Approval)
TAPENTADOL 100MG · TABLET, EXTENDED RELEASE · ORAL
TAPENTADOLNone (Tentative Approval)
TAPENTADOL 250MG · TABLET, EXTENDED RELEASE · ORAL
TAPENTADOLNone (Tentative Approval)
TAPENTADOL 150MG · TABLET, EXTENDED RELEASE · ORAL
Approval history
2026-02-13UNKNOWN · Original · standardTA
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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