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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 218863
Company: AMNEAL

Products on ANDA 218863

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 218863

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
01/10/2025	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 218863

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

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

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

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