APPLICATION
ANDA078926
TYPE
ANDA
ORIGINAL APPROVAL
2011-02-11
LATEST ACTION
2025-09-19
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2025-09-19Labeling · Supplement 20 · standardAP
2024-10-03Labeling · Supplement 19 · standardAP
2021-09-09Labeling · Supplement 18 · standardAP
2020-10-28Labeling · Supplement 9 · standardAP
2020-10-28Labeling · Supplement 17 · standardAP
2020-10-28Labeling · Supplement 15 · standardAP
2020-10-28Labeling · Supplement 12 · standardAP
2020-10-28Labeling · Supplement 10 · standardAP
2014-11-08Labeling · Supplement 7 · standardAP
2014-11-08Labeling · Supplement 5 · standardAP
2012-04-11Labeling · Supplement 2AP
2011-08-30Labeling · Supplement 1AP
2011-02-11OriginalAP
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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