← FDA DRUG APPROVALS

FDA ANDA · ANDA209743

PREGABALIN

Sponsor: AMNEAL PHARMS CO

APPLICATION
ANDA209743
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-19
LATEST ACTION
2025-07-07
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

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
PREGABALINPrescription
PREGABALIN 150MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 75MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 25MG · CAPSULE · ORAL

Approval history

2025-07-07Labeling · Supplement 19 · standardAP
2024-07-15Labeling · Supplement 18 · standardAP
2023-06-09Labeling · Supplement 17 · standardAP
2023-06-09Labeling · Supplement 5 · standardAP
2023-06-09Labeling · Supplement 14 · standardAP
2019-07-19UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

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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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