APPLICATION
ANDA214957
TYPE
ANDA
ORIGINAL APPROVAL
2021-10-01
LATEST ACTION
2026-04-28
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 800MG · TABLET · ORAL
GABAPENTINPrescription
GABAPENTIN 600MG · TABLET · ORAL
Approval history
2026-04-28Labeling · Supplement 7 · standardAP
2026-04-28Labeling · Supplement 5 · standardAP
2021-10-01UNKNOWN · Original · 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.