Drugs@FDA: FDA-Approved Drugs

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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
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

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