APPLICATION
ANDA212865
TYPE
ANDA
ORIGINAL APPROVAL
2020-03-20
LATEST ACTION
2024-12-23
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PREGABALINPrescription
PREGABALIN 150MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 75MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 100MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 50MG · CAPSULE · ORAL
Approval history
2024-12-23Labeling · Supplement 4 · standardAP
2024-12-23Labeling · Supplement 1 · standardAP
2020-03-20UNKNOWN · 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.