NDA 208564

THERAPEUTICSMD INC

FDA Drug Application

Application #208564

Documents

• Label: 2018-05-31
• Letter: 2018-06-01
• Review: 2019-02-01
• Label: 2019-11-22
• Letter: 2019-11-22
• Letter: 2021-11-17
• Label: 2021-11-17

Application Sponsors

NDA 208564

THERAPEUTICSMD INC

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	INSERT;VAGINAL	0.004MG	1	IMVEXXY	ESTRADIOL
002	INSERT;VAGINAL	0.01MG	1	IMVEXXY	ESTRADIOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer	ORIG	1	AP	2018-05-29	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-11-16	STANDARD
LABELING; Labeling	SUPPL	3	AP	2019-11-21	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15
SUPPL	3	Null	7

CDER Filings

THERAPEUTICSMD INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208564
            [companyName] => THERAPEUTICSMD INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"IMVEXXY","activeIngredients":"ESTRADIOL","strength":"0.004MG","dosageForm":"INSERT;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"IMVEXXY","activeIngredients":"ESTRADIOL","strength":"0.01MG","dosageForm":"INSERT;VAGINAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/21\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208564s003lbl.pdf\"}]","notes":""},{"actionDate":"05\/29\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/208564s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"05\/29\/2018","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\\\/2018\\\/208564s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/208564Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/208564Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => [{"actionDate":"11\/21\/2019","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/208564s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/208564Orig1s003ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-11-21
        )

)