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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 210130
Company: MYLAN

Products on ANDA 210130

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 210130

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/19/2019	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/210130Orig1s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/23/2024	SUPPL-7	Labeling-Container/Carton Labels, Labeling-Patient Package Insert		Label is not available on this site.
08/25/2021	SUPPL-3	Labeling-Container/Carton Labels		Label is not available on this site.
02/23/2021	SUPPL-2	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 210130

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	210130	MYLAN

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	210130	MYLAN

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	210130	MYLAN

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