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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 204988
Company: HIKMA

Products on ANDA 204988

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
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 204988

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/16/2016	ORIG-1	Approval		STANDARD	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204988Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/204988Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/16/2020	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Labels for ANDA 204988

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/16/2016	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/204988Orig1s000lbl.pdf

Therapeutic Equivalents for ANDA 204988

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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