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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 214138
Company: ALKEM LABS LTD

Products on ANDA 214138

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	AB	No	No
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 214138

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/2021	ORIG-1	Approval		STANDARD		Label is not available on this site.

Therapeutic Equivalents for ANDA 214138

EVEROLIMUS

TABLET;ORAL; 0.25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

TABLET;ORAL; 0.5MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

TABLET;ORAL; 0.75MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	214138	ALKEM LABS LTD
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	205775	PAR PHARM
ZORTRESS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

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