NDA 209627

THERAPEUTICSMD INC

FDA Drug Application

Application #209627

Documents

• Label: 2018-08-10
• Letter: 2018-08-17
• Review: 2018-09-10
• Label: 2022-05-04

Application Sponsors

NDA 209627

THERAPEUTICSMD INC

Marketing Status

• Prescription: 001

Application Products

001

RING;VAGINAL

0.013MG/24HR;0.15MG/24HR

1

ANNOVERA

ETHINYL ESTRADIOL; SEGESTERONE ACETATE

FDA Submissions

TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination	ORIG	1	AP	2018-08-10	STANDARD
LABELING; Labeling	SUPPL	3	AP	2022-04-29	STANDARD

Submissions Property Types

ORIG	1	Null	40
SUPPL	3	Null	7

CDER Filings

THERAPEUTICSMD INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209627
            [companyName] => THERAPEUTICSMD INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ANNOVERA","activeIngredients":"ETHINYL ESTRADIOL; SEGESTERONE ACETATE","strength":"0.013MG\/24HR;0.15MG\/24HR","dosageForm":"RING;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"08\/10\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209627s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"08\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity and Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209627s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209627Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/209627Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2018-08-10
        )

)