APPLICATION
ANDA211592
TYPE
ANDA
ORIGINAL APPROVAL
2019-12-03
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 10AP
2024-09-12REMS · Supplement 9AP
2022-10-28Labeling · Supplement 5 · standardAP
2022-10-28Labeling · Supplement 3 · standardAP
2022-10-12REMS · Supplement 6AP
2020-10-02REMS · Supplement 4AP
2020-04-17REMS · 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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