Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214848
Company: AUROBINDO PHARMA LTD

Products on ANDA 214848

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIVARACETAM	BRIVARACETAM	50MG	TABLET;ORAL	Prescription	AB	No	No
BRIVARACETAM	BRIVARACETAM	100MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214848

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/06/2023	ORIG-1	Approval		STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
01/29/2025	SUPPL-2	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.
06/04/2024	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 214848

BRIVARACETAM

TABLET;ORAL; 50MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVARACETAM	BRIVARACETAM	50MG	TABLET;ORAL	Prescription	No	AB	214848	AUROBINDO PHARMA LTD
BRIVARACETAM	BRIVARACETAM	50MG	TABLET;ORAL	Prescription	No	AB	214921	MSN
BRIVIACT	BRIVARACETAM	50MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC

TABLET;ORAL; 100MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVARACETAM	BRIVARACETAM	100MG	TABLET;ORAL	Prescription	No	AB	214848	AUROBINDO PHARMA LTD
BRIVARACETAM	BRIVARACETAM	100MG	TABLET;ORAL	Prescription	No	AB	214921	MSN
BRIVIACT	BRIVARACETAM	100MG	TABLET;ORAL	Prescription	Yes	AB	205836	UCB INC