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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 207486
Company: HIKMA

Products on ANDA 207486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 207486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/23/2021	ORIG-2	Approval		STANDARD		Label is not available on this site.
06/08/2020	ORIG-1	Approval		STANDARD	Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207486Orig1s000TAltr.pdf

Therapeutic Equivalents for ANDA 207486

EVEROLIMUS

TABLET;ORAL; 2.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	Yes	AB	022334	NOVARTIS
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	214182	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	205426	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	207934	ENDO OPERATIONS
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	210050	TEVA PHARMS USA

TABLET;ORAL; 5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	Yes	AB	022334	NOVARTIS
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	214182	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	205426	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	207934	ENDO OPERATIONS
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	210050	TEVA PHARMS USA

TABLET;ORAL; 7.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	Yes	AB	022334	NOVARTIS
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	214182	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	205426	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	207934	ENDO OPERATIONS
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	210050	TEVA PHARMS USA

TABLET;ORAL; 10MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AFINITOR	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	Yes	AB	022334	NOVARTIS
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	214182	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	205426	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	207934	ENDO OPERATIONS
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	210050	TEVA PHARMS USA

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