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FDA ANDA · ANDA214501

BRIVARACETAM

Sponsor: ZYDUS PHARMS

APPLICATION
ANDA214501
TYPE
ANDA
ORIGINAL APPROVAL
2022-10-03
LATEST ACTION
2022-10-03
ROUTE
ORAL
DOSAGE FORM
TABLET
MARKETING STATUS
Prescription

Products

BRIVARACETAMPrescription
BRIVARACETAM 100MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 50MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 10MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 75MG · TABLET · ORAL
BRIVARACETAMPrescription
BRIVARACETAM 25MG · TABLET · ORAL

Approval history

2022-10-03UNKNOWN · Original · standardLetterAP
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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