APPLICATION
ANDA205321
TYPE
ANDA
ORIGINAL APPROVAL
2023-03-29
LATEST ACTION
2026-06-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PREGABALINPrescription
PREGABALIN 150MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 75MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 25MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 300MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 200MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 100MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 50MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 225MG · CAPSULE · ORAL
Approval history
2026-06-23Labeling · Supplement 3 · standardAP
2024-06-05Labeling · Supplement 1 · standardAP
2023-03-29UNKNOWN · 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.