APPLICATION
ANDA078782
TYPE
ANDA
ORIGINAL APPROVAL
2011-07-21
LATEST ACTION
2016-02-29
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Discontinued
Products
GABAPENTINDiscontinued
GABAPENTIN 600MG · TABLET · ORAL
GABAPENTINDiscontinued
GABAPENTIN 800MG · TABLET · ORAL
Approval history
2016-02-29Labeling · Supplement 5 · standardAP
2016-02-29Labeling · Supplement 3 · standardAP
2016-02-29Labeling · Supplement 6 · standardAP
2012-11-28Labeling · Supplement 2 · standardAP
2012-04-17Labeling · Supplement 1AP
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.
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.