Documents
Application Sponsors
| NDA 210496 | ARRAY BIOPHARMA INC | |
Marketing Status
| Discontinued | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 50MG | 1 | BRAFTOVI | ENCORAFENIB |
| 002 | CAPSULE;ORAL | 75MG | 1 | BRAFTOVI | ENCORAFENIB |
FDA Submissions
| TYPE 1/4; Type 1 - New Molecular Entity and Type 4 - New Combination | ORIG | 1 | AP | 2018-06-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2019-05-24 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2020-04-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 13 | AP | 2022-02-11 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 40 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 6 | Null | 6 |
| SUPPL | 13 | Null | 7 |
CDER Filings
ARRAY BIOPHARMA INC
cder:Array
(
[0] => Array
(
[ApplNo] => 210496
[companyName] => ARRAY BIOPHARMA INC
[docInserts] => ["Medication Guide","https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2019\/210496s003lbl.pdf#page=18"]
[products] => [{"drugName":"BRAFTOVI","activeIngredients":"ENCORAFENIB","strength":"50MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"},{"drugName":"BRAFTOVI","activeIngredients":"ENCORAFENIB","strength":"75MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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[actionDate] => 2020-04-08
)
)