Documents
Application Sponsors
NDA 213218 | SARFEZ PHARMACEUTICALS INC | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | TABLET; ORAL | 20MG | 0 | SOAANZ | TORSEMIDE |
002 | TABLET; ORAL | 60MG | 0 | SOAANZ | TORSEMIDE |
003 | TABLET;ORAL | 40MG | 1 | SOAANZ | TORSEMIDE |
FDA Submissions
TYPE 5; Type 5 - New Formulation or New Manufacturer | ORIG | 1 | AP | 2021-06-14 | STANDARD |
Submissions Property Types
CDER Filings
SARFEZ PHARMACEUTICALS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 213218
[companyName] => SARFEZ PHARMACEUTICALS INC
[docInserts] => ["",""]
[products] => [{"drugName":"SOAANZ","activeIngredients":"TORSEMIDE","strength":"20MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"},{"drugName":"SOAANZ","activeIngredients":"TORSEMIDE","strength":"60MG","dosageForm":"TABLET; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
[labels] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213218s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"06\/14\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/213218s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/213218Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-06-14
)
)