An official website of the United States government Here's how you know

The .gov means it's official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

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	Yes

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.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
10/04/2024	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
10/04/2024	SUPPL-8	Labeling-Package Insert, Labeling-Medication Guide		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	216140	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	219533	EUGIA PHARMA
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.25MG	TABLET;ORAL	Prescription	No	AB	205775	PH HEALTH
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	216140	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	219533	EUGIA PHARMA
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.5MG	TABLET;ORAL	Prescription	No	AB	205775	PH HEALTH
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	216140	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	219533	EUGIA PHARMA
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	0.75MG	TABLET;ORAL	Prescription	No	AB	205775	PH HEALTH
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	216140	BIOCON PHARMA
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	205432	BRECKENRIDGE
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	219533	EUGIA PHARMA
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	206133	HIKMA
EVEROLIMUS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	No	AB	205775	PH HEALTH
ZORTRESS	EVEROLIMUS	1MG	TABLET;ORAL	Prescription	Yes	AB	021560	NOVARTIS

Top