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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220385
Company: INDOCO

Products on ANDA 220385

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	AA	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 220385

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 220385

BRIVARACETAM

SOLUTION;ORAL; 10MG/ML
TE Code = AA

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	219772	ALKEM LABS LTD
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	220385	INDOCO
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	220164	LUPIN
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	214922	MSN
BRIVARACETAM	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	No	AA	218494	ZHEJIANG POLY PHARM
BRIVIACT	BRIVARACETAM	10MG/ML	SOLUTION;ORAL	Prescription	Yes	AA	205838	UCB INC

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