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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207620
Company: NOVARTIS PHARMS CORP

Summary Review

Products on NDA 207620

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
ENTRESTO	SACUBITRIL; VALSARTAN	24MG;26MG	TABLET;ORAL	Prescription	None	Yes	No
ENTRESTO	SACUBITRIL; VALSARTAN	49MG;51MG	TABLET;ORAL	Prescription	None	Yes	No
ENTRESTO	SACUBITRIL; VALSARTAN	97MG;103MG	TABLET;ORAL	Prescription	None	Yes	Yes

Approval Date(s) and History, Letters, Labels, Reviews for NDA 207620

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
07/07/2015	ORIG-1	Approval	Type 1 - New Molecular Entity and Type 4 - New Combination	PRIORITY	Label (PDF) Letter (PDF) Review Summary Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207620Orig1s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/207620Orig1s000ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207620Orig1s000TOC.cfm https://www.accessdata.fda.gov/drugsatfda_docs/nda/2015/207620Orig1s000SumR.pdf

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-25	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207620s025,218591s000lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218591Orig1s000, 207620Orig1s025ltr.pdf
10/18/2023	SUPPL-24	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207620Orig1s024lbl.pdf
02/16/2021	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF) Review (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207620s018lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2021/207620Orig1s018ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/2021/207620Orig1s018.pdf
10/01/2019	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207620s013lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2019/207620Orig1s013ltr.pdf
11/22/2017	SUPPL-8	Labeling-Patient Package Insert, Labeling-Package Insert	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207620s008lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2017/207620Orig1s008ltr.pdf
12/21/2016	SUPPL-4	Manufacturing (CMC)		Label is not available on this site.
05/11/2016	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
02/12/2016	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 207620

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/12/2024	SUPPL-25	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207620s025,218591s000lbl.pdf
10/18/2023	SUPPL-24	Manufacturing (CMC)-Facility	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/207620Orig1s024lbl.pdf
02/16/2021	SUPPL-18	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/207620s018lbl.pdf
10/01/2019	SUPPL-13	Efficacy-Labeling Change With Clinical Data	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/207620s013lbl.pdf
11/22/2017	SUPPL-8	Labeling-Patient Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207620s008lbl.pdf
11/22/2017	SUPPL-8	Labeling-Package Insert	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207620s008lbl.pdf
07/07/2015	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2015/207620Orig1s000lbl.pdf

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