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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 220597
Company: NOVITIUM PHARMA

Products on ANDA 220597

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVEROLIMUS	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	AB	No	No

Therapeutic Equivalents for ANDA 220597

EVEROLIMUS

TABLET, FOR SUSPENSION;ORAL; 2MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR DISPERZ	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	203985	NOVARTIS PHARM
EVEROLIMUS	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	218863	AMNEAL
EVEROLIMUS	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	217216	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	217640	NATCO
EVEROLIMUS	EVEROLIMUS	2MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	220597	NOVITIUM PHARMA

TABLET, FOR SUSPENSION;ORAL; 3MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR DISPERZ	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	203985	NOVARTIS PHARM
EVEROLIMUS	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	218863	AMNEAL
EVEROLIMUS	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	217216	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	217640	NATCO
EVEROLIMUS	EVEROLIMUS	3MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	220597	NOVITIUM PHARMA

TABLET, FOR SUSPENSION;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR DISPERZ	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	Yes	AB	203985	NOVARTIS PHARM
EVEROLIMUS	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	218863	AMNEAL
EVEROLIMUS	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	217216	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	217640	NATCO
EVEROLIMUS	EVEROLIMUS	5MG	TABLET, FOR SUSPENSION;ORAL	Prescription	No	AB	220597	NOVITIUM PHARMA

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