Drugs@FDA: FDA-Approved Drugs
New Drug Application (NDA): 218591
Company: NOVARTIS
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 |