APPLICATION
ANDA075360
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-06
LATEST ACTION
2025-08-26
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
Approval history
2025-08-26Labeling · Supplement 35 · standardAP
2024-12-19Labeling · Supplement 34 · standardAP
2021-03-05Labeling · Supplement 28 · standardAP
2020-07-28Labeling · Supplement 22 · standardAP
2020-07-28Labeling · Supplement 19 · standardAP
2020-07-28Labeling · Supplement 25 · standardAP
2020-07-28Labeling · Supplement 23 · standardAP
2015-09-17Labeling · Supplement 18 · standardAP
2015-04-17Labeling · Supplement 17 · standardAP
2015-04-17Labeling · Supplement 13 · standardAP
2015-04-17Labeling · Supplement 11 · standardAP
2011-08-29Labeling · Supplement 10AP
2010-08-03Labeling · Supplement 7AP
2007-04-25Labeling · Supplement 5AP
2006-12-07Labeling · Supplement 3AP
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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