Drugs@FDA: FDA Approved Drug Products

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

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

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 208813 RISING

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