NDA 214154

MAYNE PHARMA

FDA Drug Application

Application #214154

Documents

• Label: 2021-04-15
• Letter: 2021-04-16
• Review: 2021-05-12
• Label: 2022-05-02
• Letter: 2022-05-03

Application Sponsors

NDA 214154

MAYNE PHARMA

Marketing Status

• Prescription: 001

Application Products

001

TABLET, CHEWABLE, TABLET, CAPSULE; ORAL

3MG;14.2MG

0

NEXTSTELLIS

DROSPIRENONE;ESTETROL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	2021-04-15	STANDARD
LABELING; Labeling	SUPPL	2	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	2	Null	6

CDER Filings

MAYNE PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214154
            [companyName] => MAYNE PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"NEXTSTELLIS","activeIngredients":"DROSPIRENONE;ESTETROL","strength":"3MG;14.2MG","dosageForm":"TABLET, CHEWABLE, TABLET, CAPSULE; ORAL","marketingStatus":"Prescription","te":"None","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"04\/15\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214154s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"04\/15\/2021","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214154s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214154Orig1s000ltr.pdf\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2021-04-15
        )

)