Documents
Application Sponsors
NDA 214846 | MYOVANT SCIENCES | |
Marketing Status
Application Products
001 | TABLET;ORAL | 40MG;1MG;0.5MG | 2 | MYFEMBREE | RELUGOLIX;ESTRADIOL;NORETHINDRONE ACETATE |
FDA Submissions
TYPE 4; Type 4 - New Combination | ORIG | 1 | AP | 2021-05-26 | STANDARD |
EFFICACY; Efficacy | SUPPL | 2 | AP | 2022-08-05 | STANDARD |
EFFICACY; Efficacy | SUPPL | 5 | AP | 2023-01-27 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2023-01-27 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 6 |
SUPPL | 2 | Null | 12 |
SUPPL | 5 | Null | 6 |
SUPPL | 6 | Null | 6 |
TE Codes
CDER Filings
MYOVANT SCIENCES
cder:Array
(
[0] => Array
(
[ApplNo] => 214846
[companyName] => MYOVANT SCIENCES
[docInserts] => ["",""]
[products] => [{"drugName":"MYFEMBREE","activeIngredients":"RELUGOLIX;ESTRADIOL;NORETHINDRONE ACETATE","strength":"40MG;1MG;0.5MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"05\/26\/2021","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2021\\\/214846s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"05\/26\/2021","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\\\/2021\\\/214846s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2021\\\/214846Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2021-05-26
)
)