APPLICATION
ANDA090007
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-21
LATEST ACTION
2025-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2025-08-18Labeling · Supplement 14 · standardAP
2025-08-18Labeling · Supplement 13 · standardAP
2023-03-17Labeling · Supplement 9 · standardAP
2020-08-20Labeling · Supplement 8 · standardAP
2020-08-20Labeling · Supplement 6 · standardAP
2020-08-20Labeling · Supplement 4 · standardAP
2020-08-20Labeling · Supplement 5 · standardAP
2020-08-20Labeling · Supplement 3 · standardAP
2014-11-08Labeling · Supplement 2 · standardAP
2011-07-21OriginalAP
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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