Documents
Application Sponsors
| NDA 207620 | NOVARTIS PHARMS CORP | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | 24MG;26MG | 1 | ENTRESTO | SACUBITRIL; VALSARTAN |
| 002 | TABLET;ORAL | 49MG;51MG | 1 | ENTRESTO | SACUBITRIL; VALSARTAN |
| 003 | TABLET;ORAL | 97MG;103MG | 1 | ENTRESTO | SACUBITRIL; VALSARTAN |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2015-07-07 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 2 | AP | 2016-05-11 | PRIORITY |
| MANUF (CMC); Manufacturing (CMC) | SUPPL | 4 | AP | 2016-12-21 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2017-11-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2019-10-01 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 18 | AP | 2021-02-16 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 0 |
| SUPPL | 8 | Null | 7 |
| SUPPL | 13 | Null | 7 |
| SUPPL | 18 | Null | 23 |
CDER Filings
NOVARTIS PHARMS CORP
cder:Array
(
[0] => Array
(
[ApplNo] => 207620
[companyName] => NOVARTIS PHARMS CORP
[docInserts] => ["",""]
[products] => [{"drugName":"ENTRESTO","activeIngredients":"SACUBITRIL; VALSARTAN","strength":"24MG;26MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ENTRESTO","activeIngredients":"SACUBITRIL; VALSARTAN","strength":"49MG;51MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ENTRESTO","activeIngredients":"SACUBITRIL; VALSARTAN","strength":"97MG;103MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207620s013lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207620s008lbl.pdf\"}]","notes":""},{"actionDate":"11\/22\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207620s008lbl.pdf\"}]","notes":""},{"actionDate":"07\/07\/2015","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207620Orig1s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/07\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2015\\\/207620Orig1s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2015\\\/207620Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207620Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2015\\\/207620Orig1s000SumR.pdf\"}]","notes":">"}]
[supplements] => [{"actionDate":"10\/01\/2019","submission":"SUPPL-13","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207620s013lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207620Orig1s013ltr.pdf\"}]","notes":">"},{"actionDate":"11\/22\/2017","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/207620s008lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207620Orig1s008ltr.pdf\"}]","notes":">"},{"actionDate":"12\/21\/2016","submission":"SUPPL-4","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"05\/11\/2016","submission":"SUPPL-2","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"02\/12\/2016","submission":"SUPPL-1","supplementCategories":"Manufacturing (CMC)","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-10-01
)
)