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FDA ANDA · ANDA208181

TIAGABINE HYDROCHLORIDE

Sponsor: AMNEAL PHARMS CO

APPLICATION
ANDA208181
TYPE
ANDA
ORIGINAL APPROVAL
2017-12-08
LATEST ACTION
2017-12-08
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued

Products

TIAGABINE HYDROCHLORIDEDiscontinued
TIAGABINE HYDROCHLORIDE 16MG · TABLET · ORAL
TIAGABINE HYDROCHLORIDEDiscontinued
TIAGABINE HYDROCHLORIDE 4MG · TABLET · ORAL
TIAGABINE HYDROCHLORIDEDiscontinued
TIAGABINE HYDROCHLORIDE 12MG · TABLET · ORAL
TIAGABINE HYDROCHLORIDEDiscontinued
TIAGABINE HYDROCHLORIDE 2MG · TABLET · ORAL

Approval history

2017-12-08UNKNOWN · Original · standardAP
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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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