APPLICATION
ANDA077525
TYPE
ANDA
ORIGINAL APPROVAL
2006-08-24
LATEST ACTION
2024-12-02
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2024-12-02Labeling · Supplement 39 · standardAP
2024-12-02Labeling · Supplement 35 · standardAP
2020-10-27Labeling · Supplement 20 · standardAP
2020-10-27Labeling · Supplement 34 · standardAP
2020-10-27Labeling · Supplement 26 · standardAP
2020-10-27Labeling · Supplement 24 · standardAP
2015-09-10Labeling · Supplement 19 · standardAP
2014-12-12Labeling · Supplement 12 · standardAP
2014-12-12Labeling · Supplement 17 · standardAP
2010-05-14Labeling · Supplement 8AP
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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