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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 209935
Company: NOVARTIS

Summary Review

Products on NDA 209935

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KISQALI FEMARA CO-PACK (COPACKAGED)	LETROZOLE; RIBOCICLIB SUCCINATE	2.5MG;EQ 200MG BASE	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 209935

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
02/11/2025	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209092Orig1s023,209935Orig1s029lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2025/209092Orig1s023,209935Orig1s029ltr.pdf
09/03/2024	SUPPL-28	Manufacturing (CMC)-Facility	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
09/17/2024	SUPPL-27	Efficacy-New Indication	Label (PDF) Letter (PDF) Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209935Orig1s027lbl.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-25	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209935s025lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/209092Orig1s016;209935Orig1s025ltr.pdf
10/03/2022	SUPPL-21	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
05/04/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209935Orig1s019lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/209935Orig1s019ltr.pdf
12/10/2021	SUPPL-14	Efficacy-New Patient Population	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s014lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s008;209935Orig1s014ltr.pdf
09/15/2021	SUPPL-13	Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/209092Orig1s009; 209935Orig1s013ltr.pdf
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

Labels for NDA 209935

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/11/2025	SUPPL-29	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/209092Orig1s023,209935Orig1s029lbl.pdf
09/17/2024	SUPPL-27	Efficacy-New Indication	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209935Orig1s027lbl.pdf
09/03/2024	SUPPL-28	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/209092Orig1s020, 209935Orig1s028lbl.pdf
08/24/2023	SUPPL-25	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/209935s025lbl.pdf
10/03/2022	SUPPL-21	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209092s013,209935s021lbl.pdf
05/04/2022	SUPPL-19	Labeling-Container/Carton Labels	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/209935Orig1s019lbl.pdf
12/10/2021	SUPPL-14	Efficacy-New Patient Population	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s014lbl.pdf
09/15/2021	SUPPL-13	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/209935s013lbl.pdf
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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