APPLICATION
ANDA210196
TYPE
ANDA
ORIGINAL APPROVAL
2018-06-21
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
VIGADRONEPrescription
VIGABATRIN 500MG/PACKET · FOR SOLUTION · ORAL
Approval history
2026-03-18REMS · Supplement 22AP
2024-09-12REMS · Supplement 20AP
2022-10-12REMS · Supplement 14AP
2022-08-08Labeling · Supplement 6 · standardAP
2022-08-08Labeling · Supplement 4 · standardAP
2022-08-08Labeling · Supplement 2 · standardAP
2022-08-08Labeling · Supplement 12 · standardAP
2020-10-02REMS · Supplement 7AP
2020-04-17REMS · Supplement 5AP
2019-09-12REMS · Supplement 3AP
2019-05-30REMS · Supplement 1AP
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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