Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 211031
Company: BRECKENRIDGE

Products on ANDA 211031

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	AB	No	No

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 211031

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
02/21/2019	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
06/15/2022	SUPPL-3	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 211031

EXEMESTANE

TABLET;ORAL; 25MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
AROMASIN	EXEMESTANE	25MG	TABLET;ORAL	Prescription	Yes	AB	020753	PFIZER
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	211031	BRECKENRIDGE
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	210323	CIPLA
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	216454	EUGIA PHARMA
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	213547	QILU
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	203315	RISING
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	209208	UPSHER SMITH LABS
EXEMESTANE	EXEMESTANE	25MG	TABLET;ORAL	Prescription	No	AB	202602	ZYDUS PHARMS