NDA 211367

EXELTIS USA INC

FDA Drug Application

Application #211367

Documents

• Label: 2019-05-24
• Letter: 2019-05-24
• Review: 2020-02-11
• Pediatric Other: 1900-01-01

Application Sponsors

NDA 211367

EXELTIS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

4MG

1

SLYND

DROSPIRENONE

FDA Submissions

TYPE 2/3; Type 2 - New Active Ingredient and Type 3 - New Dosage Form

ORIG

1

AP

2019-05-23

STANDARD

Submissions Property Types

ORIG

1

Null

40

CDER Filings

EXELTIS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 211367
            [companyName] => EXELTIS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SLYND","activeIngredients":"DROSPIRENONE","strength":"4MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"05\/23\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211367s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/23\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 2 - New Active Ingredient and Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/211367s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/211367Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2019\\\/211367Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2019-05-23
        )

)