APPLICATION
ANDA075428
TYPE
ANDA
ORIGINAL APPROVAL
2006-01-24
LATEST ACTION
2026-07-16
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 100MG · CAPSULE · ORAL
GABAPENTINDiscontinued
GABAPENTIN 300MG · CAPSULE · ORAL
Approval history
2026-07-16Labeling · Supplement 7 · standardAP
2024-12-16Labeling · Supplement 6 · standardAP
2024-07-08Labeling · Supplement 4 · standardAP
2024-07-08Labeling · Supplement 5 · standardAP
2006-01-24OriginalAP
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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