APPLICATION
ANDA207099
TYPE
ANDA
ORIGINAL APPROVAL
2017-03-24
LATEST ACTION
2026-01-29
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
GABAPENTINPrescription
GABAPENTIN 300MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 400MG · CAPSULE · ORAL
GABAPENTINPrescription
GABAPENTIN 100MG · CAPSULE · ORAL
Approval history
2026-01-29Labeling · Supplement 20 · standardAP
2024-09-09Labeling · Supplement 18 · standardAP
2024-02-20Labeling · Supplement 7 · standardAP
2020-10-02Labeling · Supplement 2 · standardAP
2020-10-02Labeling · Supplement 1 · standardAP
2017-03-24UNKNOWN · 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.