APPLICATION
ANDA208113
TYPE
ANDA
ORIGINAL APPROVAL
2024-05-17
LATEST ACTION
2025-08-15
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription
Products
PREGABALINPrescription
PREGABALIN 225MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 100MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 150MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 25MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 300MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 200MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 75MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 50MG · CAPSULE · ORAL
Approval history
2025-08-15Labeling · Supplement 2 · standardAP
2024-05-17UNKNOWN · 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.
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