APPLICATION
ANDA208218
TYPE
ANDA
ORIGINAL APPROVAL
2017-04-27
LATEST ACTION
2026-03-18
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Prescription
Products
VIGABATRINPrescription
VIGABATRIN 500MG/PACKET · FOR SOLUTION · ORAL
Approval history
2026-03-18REMS · Supplement 16AP
2024-09-12REMS · Supplement 15AP
2023-10-11Labeling · Supplement 10 · standardAP
2023-10-11Labeling · Supplement 12 · standardAP
2022-10-12REMS · Supplement 13AP
2020-10-02REMS · Supplement 11AP
2020-04-17REMS · Supplement 9AP
2020-03-12Labeling · Supplement 1 · standardAP
2020-03-12Labeling · Supplement 8 · standardAP
2020-03-12Labeling · Supplement 6 · standardAP
2019-09-12REMS · Supplement 7AP
2019-05-30REMS · Supplement 4AP
2017-10-23REMS · Supplement 2AP
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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