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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 205426
Company: BRECKENRIDGE

Products on ANDA 205426

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 205426

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/05/2021	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
06/22/2023	SUPPL-9	Labeling-Container/Carton Labels		Label is not available on this site.
06/22/2023	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
06/22/2023	SUPPL-3	Labeling-Container/Carton Labels, Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 205426

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	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	212936	MYLAN
EVEROLIMUS	EVEROLIMUS	2.5MG	TABLET;ORAL	Prescription	No	AB	207934	PAR PHARM
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	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	212936	MYLAN
EVEROLIMUS	EVEROLIMUS	5MG	TABLET;ORAL	Prescription	No	AB	207934	PAR PHARM
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	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	212936	MYLAN
EVEROLIMUS	EVEROLIMUS	7.5MG	TABLET;ORAL	Prescription	No	AB	207934	PAR PHARM
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	207486	HIKMA
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	212936	MYLAN
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	207934	PAR PHARM
EVEROLIMUS	EVEROLIMUS	10MG	TABLET;ORAL	Prescription	No	AB	210050	TEVA PHARMS USA

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