Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211388
Company: BIONPHARMA INC

Products on ANDA 211388

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211388

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/23/2019	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
08/11/2020	SUPPL-1	Labeling-Medication Guide, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211388

RUFINAMIDE

SUSPENSION;ORAL; 40MG/ML
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
BANZEL	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	Yes	AB	201367	EISAI INC
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	213410	ALKEM LABS LTD
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	216549	AUROBINDO PHARMA
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	211388	BIONPHARMA INC
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	214009	CHARTWELL RX
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	207363	HIKMA
RUFINAMIDE	RUFINAMIDE	40MG/ML	SUSPENSION;ORAL	Prescription	No	AB	213457	LUPIN LTD