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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209092
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
KISQALI RIBOCICLIB SUCCINATE EQ 200MG BASE 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
03/13/2017 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/209092s000ltredt.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209092Orig1s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
09/03/2024 SUPPL-20 Manufacturing (CMC)-Packaging Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s020, 209935Orig1s028ltr.pdf
07/22/2024 SUPPL-19 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s019ltr.pdf
09/17/2024 SUPPL-18 Efficacy-New Indication Label (PDF)
Letter (PDF)
Summary Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/209092Orig1s018, 209935Orig1s027ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/209092s018,209935s027MultidisciplineR.pdf
08/24/2023 SUPPL-16 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209092s016lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209092Orig1s016;209935Orig1s025ltr.pdf
10/03/2022 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209092Orig1s013,209935Orig1s021ltr.pdf
09/15/2021 SUPPL-9 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s009lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s009; 209935Orig1s013ltr.pdf
12/10/2021 SUPPL-8 Efficacy-New Patient Population Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s008;209935Orig1s014ltr.pdf
07/06/2020 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s005lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s005, 209935Orig1s008ltr.pdf
09/09/2019 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209092s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/209092Orig1s004ltr.pdf
01/21/2020 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2020/209092Orig1s003, 209935Orig1s006ltr.pdf
07/18/2018 SUPPL-1 Efficacy-New Indication Label (PDF)
Letter (PDF)
Review (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209092s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2018/209092Orig1s001ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2019/209092Orig1s001.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
09/17/2024 SUPPL-18 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s018lbl.pdf
09/03/2024 SUPPL-20 Manufacturing (CMC)-Packaging Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf
07/22/2024 SUPPL-19 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092s019lbl.pdf
08/24/2023 SUPPL-16 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209092s016lbl.pdf
10/03/2022 SUPPL-13 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf
12/10/2021 SUPPL-8 Efficacy-New Patient Population Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s008lbl.pdf
09/15/2021 SUPPL-9 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209092s009lbl.pdf
07/06/2020 SUPPL-5 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s005lbl.pdf
01/21/2020 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209092s003lbl.pdf
09/09/2019 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/209092s004lbl.pdf
07/18/2018 SUPPL-1 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/209092s001lbl.pdf
03/13/2017 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209092s000lbl.pdf
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