Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 020497
Company: KYOWA KIRIN
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 |