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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 207620
Company: NOVARTIS PHARMS CORP
Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTRESTO SACUBITRIL; VALSARTAN 24MG;26MG TABLET;ORAL Prescription AB Yes No
ENTRESTO SACUBITRIL; VALSARTAN 49MG;51MG TABLET;ORAL Prescription AB Yes No
ENTRESTO SACUBITRIL; VALSARTAN 97MG;103MG TABLET;ORAL Prescription AB 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
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/appletter/2024/218591Orig1s000;207620Orig1s025ltr.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-Package Insert, Labeling-Patient 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.

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/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) 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-Package Insert Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/207620s008lbl.pdf
11/22/2017 SUPPL-8 Labeling-Patient 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

ENTRESTO

TABLET;ORAL; 24MG;26MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENTRESTO SACUBITRIL; VALSARTAN 24MG;26MG TABLET;ORAL Prescription Yes AB 207620 NOVARTIS PHARMS CORP
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET;ORAL Prescription No AB 213682 ALEMBIC
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET;ORAL Prescription No AB 213605 CRYSTAL
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET;ORAL Prescription No AB 213676 LAURUS
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 24MG;26MG TABLET;ORAL Prescription No AB 213719 ZYDUS PHARMS

TABLET;ORAL; 49MG;51MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENTRESTO SACUBITRIL; VALSARTAN 49MG;51MG TABLET;ORAL Prescription Yes AB 207620 NOVARTIS PHARMS CORP
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET;ORAL Prescription No AB 213682 ALEMBIC
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET;ORAL Prescription No AB 213605 CRYSTAL
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET;ORAL Prescription No AB 213676 LAURUS
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 49MG;51MG TABLET;ORAL Prescription No AB 213719 ZYDUS PHARMS

TABLET;ORAL; 97MG;103MG
TE Code = AB

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code Application No. Company
ENTRESTO SACUBITRIL; VALSARTAN 97MG;103MG TABLET;ORAL Prescription Yes AB 207620 NOVARTIS PHARMS CORP
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET;ORAL Prescription No AB 213682 ALEMBIC
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET;ORAL Prescription No AB 213605 CRYSTAL
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET;ORAL Prescription No AB 213676 LAURUS
SACUBITRIL AND VALSARTAN SACUBITRIL; VALSARTAN 97MG;103MG TABLET;ORAL Prescription No AB 213719 ZYDUS PHARMS
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