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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 218591
Company: NOVARTIS

Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status TE Code RLD RS
ENTRESTO SACUBITRIL;VALSARTAN 97MG;103MG TABLET;ORAL Prescription None No No
ENTRESTO SPRINKLE SACUBITRIL; VALSARTAN 6MG;6MG CAPSULE, PELLETS;ORAL Prescription None Yes No
ENTRESTO SPRINKLE SACUBITRIL; VALSARTAN 15MG;16MG CAPSULE, PELLETS;ORAL Prescription None Yes Yes
ENTRESTO SPRINKLE SACUBITRIL;VALSARTAN 6MG;6MG CAPSULE, COATED PELLETS;ORAL Prescription None No No
ENTRESTO SPRINKLE SACUBITRIL;VALSARTAN 15MG;16MG CAPSULE, PELLETS;ORAL Prescription None No 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
04/12/2024 ORIG-1 Approval Type 3 - New Dosage Form STANDARD Label (PDF)
Letter (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 https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218591Orig1s000, 207620Orig1s025ltr.pdf

Action Date Submission Supplement Categories or Approval Type Letters, Reviews, Labels,
Patient Package Insert		 Note Url
04/12/2024 ORIG-1 Approval Label (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/207620s025,218591s000lbl.pdf
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