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FDA ANDA · ANDA216197

PREGABALIN

Sponsor: ADAPTIS

APPLICATION
ANDA216197
TYPE
ANDA
ORIGINAL APPROVAL
2022-07-18
LATEST ACTION
2025-09-17
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

2025-09-17Labeling · Supplement 3 · standardAP
2024-01-24Labeling · Supplement 1 · standardAP
2024-01-24Labeling · Supplement 2 · standardAP
2022-07-18UNKNOWN · 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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