APPLICATION
ANDA078150
TYPE
ANDA
ORIGINAL APPROVAL
2007-09-25
LATEST ACTION
2023-08-02
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 300MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 100MG · CAPSULE · ORAL
Approval history
2023-08-02Labeling · Supplement 18 · standardAP
2020-08-10Labeling · Supplement 17 · standardAP
2020-08-10Labeling · Supplement 16 · standardAP
2012-07-20Manufacturing (CMC) · Supplement 14AP
2012-04-30Labeling · Supplement 13AP
2012-04-05Manufacturing (CMC) · Supplement 8AP
2012-04-05Manufacturing (CMC) · Supplement 10AP
2011-11-25Labeling · Supplement 12AP
2011-08-29Labeling · Supplement 9AP
2009-11-18Labeling · Supplement 2AP
2007-09-25OriginalAP
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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