APPLICATION
ANDA213390
TYPE
ANDA
ORIGINAL APPROVAL
2021-07-29
LATEST ACTION
2024-09-12
ROUTE
ORAL
DOSAGE FORM
FOR SOLUTION
MARKETING STATUS
Discontinued
Products
VIGABATRINDiscontinued
VIGABATRIN 500MG/PACKET · FOR SOLUTION · ORAL
Approval history
2024-09-12REMS · Supplement 3AP
2022-10-26Labeling · Supplement 1 · standardAP
2022-10-12REMS · Supplement 2AP
2021-07-29UNKNOWN · 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.
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