APPLICATION
ANDA077661
TYPE
ANDA
ORIGINAL APPROVAL
2006-09-13
LATEST ACTION
2026-06-25
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2026-06-25Labeling · Supplement 25 · standardAP
2023-09-21Labeling · Supplement 22 · standardAP
2023-09-21Labeling · Supplement 20 · standardAP
2020-10-21Labeling · Supplement 18 · standardAP
2020-10-21Labeling · Supplement 16 · standardAP
2020-10-21Labeling · Supplement 14 · standardAP
2020-10-21Labeling · Supplement 19 · standardAP
2015-09-17Labeling · Supplement 13 · standardAP
2015-04-17Labeling · Supplement 8 · standardAP
2015-04-17Labeling · Supplement 12 · standardAP
2013-04-09REMS · Supplement 9AP
2011-08-26Labeling · Supplement 7AP
2011-01-31Labeling · Supplement 4AP
2010-08-03Labeling · Supplement 3AP
2006-09-13OriginalAP
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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