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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020497
Company: KYOWA KIRIN

Products on NDA 020497

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FARESTON	TOREMIFENE CITRATE	EQ 60MG BASE	TABLET;ORAL	Prescription	AB	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020497

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
05/29/1997	ORIG-1	Approval	Type 1 - New Molecular Entity	STANDARD; Orphan		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2017	SUPPL-9	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020497s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/020497Orig1s009ltr.pdf
03/21/2011	SUPPL-6	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020497s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020497s006ltr.pdf
07/10/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
12/01/1998	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
11/20/1997	SUPPL-1	Labeling		Label is not available on this site.

Labels for NDA 020497

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/12/2017	SUPPL-9	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/020497s009lbl.pdf
03/21/2011	SUPPL-6	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020497s006lbl.pdf

Therapeutic Equivalents for NDA 020497

FARESTON

TABLET;ORAL; EQ 60MG BASE
TE Code = AB

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	RLD	TE Code	Application No.	Company
FARESTON	TOREMIFENE CITRATE	EQ 60MG BASE	TABLET;ORAL	Prescription	Yes	AB	020497	KYOWA KIRIN
TOREMIFENE CITRATE	TOREMIFENE CITRATE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	212818	MSN
TOREMIFENE CITRATE	TOREMIFENE CITRATE	EQ 60MG BASE	TABLET;ORAL	Prescription	No	AB	208813	RISING

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