APPLICATION
ANDA214816
TYPE
ANDA
ORIGINAL APPROVAL
2021-11-16
LATEST ACTION
2021-11-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
TIAGABINE HYDROCHLORIDEPrescription
TIAGABINE HYDROCHLORIDE 16MG · TABLET · ORAL
TIAGABINE HYDROCHLORIDEPrescription
TIAGABINE HYDROCHLORIDE 4MG · TABLET · ORAL
TIAGABINE HYDROCHLORIDEPrescription
TIAGABINE HYDROCHLORIDE 12MG · TABLET · ORAL
TIAGABINE HYDROCHLORIDEPrescription
TIAGABINE HYDROCHLORIDE 2MG · TABLET · ORAL
Approval history
2021-11-16UNKNOWN · Original · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.