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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 077431
Company: HIKMA

Products on ANDA 077431

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 077431

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
04/01/2011	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/077431s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
06/15/2022	SUPPL-10	Labeling-Package Insert		Label is not available on this site.
08/13/2020	SUPPL-9	Labeling-Package Insert		Label is not available on this site.
08/13/2020	SUPPL-8	Labeling-Package Insert		Label is not available on this site.
07/06/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
07/06/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
08/03/2011	SUPPL-1	Labeling-Package Insert		Label is not available on this site.

Therapeutic Equivalents for ANDA 077431

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	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

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