APPLICATION
ANDA075694
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-21
LATEST ACTION
2025-09-12
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2025-09-12Labeling · Supplement 57 · standardAP
2024-12-17Labeling · Supplement 56 · standardAP
2022-07-19Labeling · Supplement 43 · standardAP
2022-07-19Labeling · Supplement 50 · standardAP
2022-07-19Labeling · Supplement 42 · standardAP
2022-07-19Labeling · Supplement 49 · standardAP
2022-07-19Labeling · Supplement 53 · standardAP
2016-01-04Labeling · Supplement 37 · standardAP
2016-01-04Labeling · Supplement 34 · standardAP
2016-01-04Manufacturing (CMC) · Supplement 30 · unknownAP
2014-11-03Labeling · Supplement 31 · standardAP
2012-04-11Labeling · Supplement 24AP
2011-08-29Labeling · Supplement 21AP
2011-03-30REMS · Supplement 20AP
2009-11-18Labeling · Supplement 16AP
2005-12-23Labeling · Supplement 5AP
2005-05-17Labeling · 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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