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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204964
Company: LUPIN LTD

Products on ANDA 204964

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RUFINAMIDE	RUFINAMIDE	100MG	TABLET;ORAL	Prescription	None	No	No
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	AB	No	No
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 204964

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/17/2022	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/204964Orig1s000ltr.pdf

Therapeutic Equivalents for ANDA 204964

RUFINAMIDE

TABLET;ORAL; 200MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BANZEL	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	Yes	AB	021911	EISAI INC
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	217230	AUROBINDO PHARMA
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	205075	GLENMARK PHARMS LTD
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204993	HETERO LABS LTD III
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204988	HIKMA
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	204964	LUPIN LTD
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	216688	MICRO LABS
RUFINAMIDE	RUFINAMIDE	200MG	TABLET;ORAL	Prescription	No	AB	205095	MYLAN

TABLET;ORAL; 400MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BANZEL	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	Yes	AB	021911	EISAI INC
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	217230	AUROBINDO PHARMA
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	205075	GLENMARK PHARMS LTD
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	204993	HETERO LABS LTD III
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	204988	HIKMA
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	204964	LUPIN LTD
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	216688	MICRO LABS
RUFINAMIDE	RUFINAMIDE	400MG	TABLET;ORAL	Prescription	No	AB	205095	MYLAN

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