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FDA ANDA · ANDA091025

PREGABALIN

Sponsor: ACTAVIS ELIZABETH

APPLICATION
ANDA091025
TYPE
ANDA
ORIGINAL APPROVAL
2020-07-09
LATEST ACTION
2025-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Discontinued

Products

PREGABALINDiscontinued
PREGABALIN 200MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 100MG · CAPSULE · ORAL
PREGABALINDiscontinued
PREGABALIN 50MG · CAPSULE · ORAL
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

Approval history

2025-08-18Labeling · Supplement 7 · standardAP
2025-03-04Labeling · Supplement 6 · standardAP
2023-06-09Labeling · Supplement 4 · standardAP
2020-07-09OriginalAP
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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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