APPLICATION
ANDA212988
TYPE
ANDA
ORIGINAL APPROVAL
2022-03-08
LATEST ACTION
2026-03-30
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
2026-03-30Labeling · Supplement 3 · standardAP
2023-07-21Manufacturing (CMC) · Supplement 1 · unknownAP
2022-03-08UNKNOWN · 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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