NDA 213218

SARFEZ PHARMACEUTICALS INC

FDA Drug Application

Application #213218

Documents

• Letter: 2021-06-15
• Label: 2021-06-15
• Label: 2022-01-19
• Review: 2022-05-16

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

ORIG

1

Null

6

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
        )

)