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FDA ANDA · ANDA207799

PREGABALIN

Sponsor: ALKEM LABS LTD

APPLICATION
ANDA207799
TYPE
ANDA
ORIGINAL APPROVAL
2019-07-19
LATEST ACTION
2025-08-18
ROUTE
ORAL
DOSAGE FORM
CAPSULE
MARKETING STATUS
Prescription

Products

PREGABALINPrescription
PREGABALIN 50MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 300MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 200MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 100MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 25MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 225MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 150MG · CAPSULE · ORAL
PREGABALINPrescription
PREGABALIN 75MG · CAPSULE · ORAL

Approval history

2025-08-18Labeling · Supplement 15 · standardAP
2024-12-19Labeling · Supplement 13 · standardAP
2023-06-21Labeling · Supplement 7 · standardAP
2023-06-21Labeling · Supplement 1 · standardAP
2019-07-19UNKNOWN · Original · standardAP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

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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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