APPLICATION
ANDA075435
TYPE
ANDA
ORIGINAL APPROVAL
2004-10-08
LATEST ACTION
2026-05-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2026-05-07Labeling · Supplement 29 · standardAP
2026-05-07Labeling · Supplement 30 · standardAP
2013-07-10Labeling · Supplement 18AP
2011-12-30Labeling · Supplement 23AP
2011-12-30Labeling · Supplement 22AP
2011-08-29Labeling · Supplement 21AP
2010-05-13Labeling · Supplement 20AP
2009-07-14Labeling · Supplement 13AP
2007-10-10Labeling · Supplement 7AP
2007-02-22Labeling · Supplement 5AP
2006-04-05Labeling · Supplement 3AP
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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