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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214880
Company: MICRO LABS

Products on ANDA 214880

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIVARACETAM	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	AP	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214880

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/23/2026	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214880

BRIVARACETAM

SOLUTION;INTRAVENOUS; 50MG/5ML (10MG/ML)
TE Code = AP

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVARACETAM	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	218249	HAINAN POLY
BRIVARACETAM	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214880	MICRO LABS
BRIVARACETAM	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	No	AP	214924	MSN
BRIVIACT	BRIVARACETAM	50MG/5ML (10MG/ML)	SOLUTION;INTRAVENOUS	Prescription	Yes	AP	205837	UCB INC

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