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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 215358
Company: NOVARTIS

Products on NDA 215358

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

Approval Date(s) and History, Letters, Labels, Reviews for NDA 215358

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

Labels for NDA 215358

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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