APPLICATION
ANDA075539
TYPE
ANDA
ORIGINAL APPROVAL
2005-04-06
LATEST ACTION
2025-12-17
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
2025-12-17Labeling · Supplement 12 · standardAP
2024-12-19Labeling · Supplement 11 · standardAP
2024-07-16Labeling · Supplement 8 · standardAP
2024-07-16Labeling · Supplement 6 · standardAP
2024-07-16Labeling · Supplement 4 · standardAP
2024-07-16Labeling · Supplement 7 · standardAP
2024-07-16Labeling · Supplement 5 · standardAP
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.
Weekly Briefing
Read a past issue →Get the Weekly GxP Briefing
Curated regulatory intelligence — enforcement, recalls, guidance, and quality signals — in one practitioner-grade email each week. Free.