Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209935
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KISQALI FEMARA CO-PACK (COPACKAGED) LETROZOLE; RIBOCICLIB SUCCINATE 2.5MG,N/A;N/A,EQ 200MG BASE TABLET, TABLET;ORAL Prescription None 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
05/04/2017 ORIG-1 Approval Type 4 - New Combination STANDARD Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209935s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209935Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209935Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
07/06/2020 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s005, 209935Orig1s008ltr.pdf
09/09/2019 SUPPL-7 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209935Orig1s007ltr.pdf
01/21/2020 SUPPL-6 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s006lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s003, 209935Orig1s006ltr.pdf
02/13/2019 SUPPL-2 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s002lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209935Orig1s002ltr.pdf
04/23/2018 SUPPL-1 Labeling-Patient Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209935s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209935Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
07/06/2020 SUPPL-8 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s008lbl.pdf
01/21/2020 SUPPL-6 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209935s006lbl.pdf
09/09/2019 SUPPL-7 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s007lbl.pdf
02/13/2019 SUPPL-2 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209935s002lbl.pdf
04/23/2018 SUPPL-1 Labeling-Patient Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209935s001lbl.pdf
05/04/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209935s000lbl.pdf

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