Drugs@FDA: FDA-Approved Drugs

Home | Previous Page

Abbreviated New Drug Application (ANDA): 200898
Company: ALVOGEN

Products on ANDA 200898

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 200898

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/28/2014	ORIG-1	Approval				Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/22/2019	SUPPL-10	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
02/22/2019	SUPPL-6	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 200898

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	200898	ALVOGEN
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	077431	HIKMA
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