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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215358
Company: NOVARTIS
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
SCEMBLIX ASCIMINIB HYDROCHLORIDE EQ 20MG BASE TABLET;ORAL Prescription None Yes No
SCEMBLIX ASCIMINIB HYDROCHLORIDE EQ 40MG BASE TABLET;ORAL Prescription None Yes Yes
SCEMBLIX ASCIMINIB HYDROCHLORIDE EQ 100MG BASE TABLET;ORAL Prescription None Yes No
Original Approvals or Tentative Approvals
Action Date Submission Action Type Submission Classification Review Priority; Orphan Status Letters, Reviews, Labels, Patient Package Insert Notes Url
10/29/2021 ORIG-2 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig2lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215358Orig2s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215358Orig1s000,Orig2s000TOC.cfm
10/29/2021 ORIG-1 Approval Type 1 - New Molecular Entity PRIORITY; Orphan Label (PDF)
Letter (PDF)
Review
https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/215358Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/215358Orig1s000,Orig2s000TOC.cfm
Supplements
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels, Patient Package Insert Note Url
10/29/2024 SUPPL-9 Efficacy-New Indication Letter (PDF)

Label is not available on this site.

https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215358Orig1s009ltr.pdf
10/29/2024 SUPPL-8 Efficacy-New Indication Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215358Orig1s008ltr.pdf
08/07/2024 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358s007lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/215358Orig1s007ltr.pdf
06/18/2024 SUPPL-5

Label is not available on this site.

11/08/2023 SUPPL-4 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215358s004lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215358Orig1s004ltr.pdf
06/26/2023 SUPPL-3 Labeling-Package Insert Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215358s003lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/215358Orig1s003ltr.pdf
10/12/2022 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF)
Letter (PDF)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215358s001lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/215358Orig1s001ltr.pdf
Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert
Note Url
10/29/2024 SUPPL-8 Efficacy-New Indication Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358Orig1s008lbl.pdf
08/07/2024 SUPPL-7 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/215358s007lbl.pdf
11/08/2023 SUPPL-4 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215358s004lbl.pdf
06/26/2023 SUPPL-3 Labeling-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/215358s003lbl.pdf
10/12/2022 SUPPL-1 Efficacy-Labeling Change With Clinical Data Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/215358s001lbl.pdf
10/29/2021 ORIG-2 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig2lbl.pdf
10/29/2021 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215358s000Orig1lbl.pdf
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