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Drugs@FDA: FDA-Approved Drugs

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Abbreviated New Drug Application (ANDA): 078921
Company: ZYDUS PHARMS USA INC

Products on ANDA 078921

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

Approval Date(s) and History, Letters, Labels, Reviews for ANDA 078921

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
06/28/2010	ORIG-1	Approval			Letter (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/078921s000ltr.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/05/2019	SUPPL-8	Labeling-Package Insert, Labeling-Patient Package Insert		Label is not available on this site.
08/13/2015	SUPPL-4	Labeling-Package Insert		Label is not available on this site.
08/13/2015	SUPPL-3	Labeling-Package Insert		Label is not available on this site.
11/14/2011	SUPPL-1	Labeling-Package Insert, Labeling-Container/Carton Labels		Label is not available on this site.

Therapeutic Equivalents for ANDA 078921

ANASTROZOLE

TABLET;ORAL; 1MG
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	090568	ACCORD HLTHCARE
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	206037	BEIJING YILING
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	091164	CIPLA
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	212434	EUGIA PHARMA
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	078944	KENTON
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	079220	NATCO PHARMA LTD
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	078058	TEVA PHARMS
ANASTROZOLE	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	No	AB	078921	ZYDUS PHARMS USA INC
ARIMIDEX	ANASTROZOLE	1MG	TABLET;ORAL	Prescription	Yes	AB	020541	ANI PHARMS

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