APPLICATION
ANDA077894
TYPE
ANDA
ORIGINAL APPROVAL
2006-10-10
LATEST ACTION
2025-09-16
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 300MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 400MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 100MG · TABLET · ORAL
Approval history
2025-09-16Labeling · Supplement 13 · standardAP
2025-03-06Labeling · Supplement 12 · standardAP
2023-08-02Labeling · Supplement 11 · standardAP
2020-10-26Labeling · Supplement 7 · standardAP
2020-10-26Labeling · Supplement 10 · standardAP
2020-10-26Labeling · Supplement 8 · standardAP
2020-10-26Labeling · Supplement 9 · standardAP
2015-09-17Labeling · Supplement 6 · standardAP
2015-04-17Labeling · Supplement 5 · standardAP
2015-04-17Labeling · Supplement 4 · standardAP
2010-08-11Labeling · Supplement 2AP
2006-10-10OriginalAP
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.