NDA 216285

EXELTIS USA INC

FDA Drug Application

Application #216285

Documents

• Letter: 2022-06-30
• Label: 2022-06-30
• Letter: 2022-12-21

Application Sponsors

NDA 216285

EXELTIS USA INC

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE;ORAL

3.5MG

0

DROSPIRENONE

DROSPIRENONE

FDA Submissions

TYPE 3; Type 3 - New Dosage Form	ORIG	1	AP	2022-06-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-12-19	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6

CDER Filings

EXELTIS USA INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 216285
            [companyName] => EXELTIS USA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"DROSPIRENONE","activeIngredients":"DROSPIRENONE","strength":"3.5MG","dosageForm":"TABLET, CHEWABLE;ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"06\/29\/2022","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216285s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"06\/29\/2022","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 3 - New Dosage Form","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2022\\\/216285s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2022\\\/216285Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2022-06-29
        )

)