APPLICATION
ANDA077242
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-24
LATEST ACTION
2024-12-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 300MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 400MG · CAPSULE · ORAL
Approval history
2024-12-02Labeling · Supplement 28 · standardAP
2024-12-02Labeling · Supplement 30 · standardAP
2024-12-02Labeling · Supplement 31 · standardAP
2020-10-27Labeling · Supplement 27 · standardAP
2020-08-07Labeling · Supplement 20 · standardAP
2020-08-07Labeling · Supplement 19 · standardAP
2020-08-07Labeling · Supplement 21 · standardAP
2015-09-10Labeling · Supplement 18 · standardAP
2014-12-12Labeling · Supplement 16 · standardAP
2014-12-12Labeling · Supplement 12 · standardAP
2011-03-30Labeling · Supplement 9AP
2011-03-30REMS · Supplement 10AP
2010-05-13Labeling · Supplement 7AP
2006-08-24OriginalAP
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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