APPLICATION
ANDA212280
TYPE
ANDA
ORIGINAL APPROVAL
2020-01-10
LATEST ACTION
2025-07-01
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued
Products
PREGABALINDiscontinued
PREGABALIN 225MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 150MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 75MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 25MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 300MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 200MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 100MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 50MG · CAPSULE · ORAL
Approval history
2025-07-01Labeling · Supplement 10 · standardAP
2024-07-31Labeling · Supplement 8 · standardAP
2023-06-09Labeling · Supplement 6 · standardAP
2023-06-09Labeling · Supplement 2 · standardAP
2020-01-10UNKNOWN · 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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