APPLICATION
ANDA220420
TYPE
ANDA
DOSAGE FORM
TABLET, EXTENDED RELEASE
MARKETING STATUS
None (Tentative Approval)
Products
GABAPENTIN ENACARBILNone (Tentative Approval)
GABAPENTIN ENACARBIL 600MG · TABLET, EXTENDED RELEASE
Approval history
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.