APPLICATION
ANDA090705
TYPE
ANDA
ORIGINAL APPROVAL
2009-12-30
LATEST ACTION
2025-05-22
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
2025-05-22Labeling · Supplement 37 · standardAP
2023-04-18Labeling · Supplement 31 · standardAP
2020-09-08Labeling · Supplement 27 · standardAP
2020-09-08Labeling · Supplement 17 · standardAP
2020-09-08Labeling · Supplement 18 · standardAP
2016-02-03Labeling · Supplement 11 · standardAP
2016-02-03Labeling · Supplement 12 · standardAP
2016-02-03Labeling · Supplement 9 · standardAP
2014-10-30Labeling · Supplement 8 · standardAP
2012-04-11Labeling · Supplement 4AP
2011-12-15Labeling · Supplement 3AP
2011-08-29Labeling · Supplement 1AP
2009-12-30OriginalAP
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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