Documents
Application Sponsors
| NDA 210132 | THERAPEUTICSMD INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 1MG;100MG | 1 | BIJUVA | ESTRADIOL; PROGESTERONE |
| 002 | CAPSULE;ORAL | 0.5MG;100MG | 1 | BIJUVA | ESTRADIOL; PROGESTERONE |
FDA Submissions
| TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2018-10-28 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2021-06-22 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-12-28 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 7 |
TE Codes
CDER Filings
THERAPEUTICSMD INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210132
[companyName] => THERAPEUTICSMD INC
[docInserts] => ["",""]
[products] => [{"drugName":"BIJUVA","activeIngredients":"ESTRADIOL; PROGESTERONE","strength":"1MG;100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"10\/28\/2018","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210132s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"10\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 4 - New Combination","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/210132s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/210132Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2018\\\/210132Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2018-10-28
)
)