APPLICATION
ANDA090335
TYPE
ANDA
ORIGINAL APPROVAL
2010-06-01
LATEST ACTION
2023-05-23
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2023-05-23Labeling · Supplement 8 · standardAP
2023-05-23Labeling · Supplement 10 · standardAP
2023-05-23Labeling · Supplement 6 · standardAP
2023-05-23Labeling · Supplement 4 · standardAP
2023-05-23Labeling · Supplement 9 · standardAP
2023-05-23Labeling · Supplement 11 · standardAP
2023-05-23Labeling · Supplement 5 · standardAP
2012-11-29Labeling · Supplement 3 · standardAP
2011-08-04REMS · Supplement 1AP
2010-06-01OriginalAP
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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