Documents
Application Sponsors
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | CAPSULE;ORAL | 100MG | 1 | ROZLYTREK | ENTRECTINIB |
| 002 | CAPSULE;ORAL | 200MG | 1 | ROZLYTREK | ENTRECTINIB |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2019-08-15 | PRIORITY |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-11-05 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2022-07-18 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 6 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 6 |
CDER Filings
GENENTECH INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212725
[companyName] => GENENTECH INC
[docInserts] => ["",""]
[products] => [{"drugName":"ROZLYTREK","activeIngredients":"ENTRECTINIB","strength":"100MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"ROZLYTREK","activeIngredients":"ENTRECTINIB","strength":"200MG","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
[labels] => [{"actionDate":"08\/15\/2019","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212725s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"08\/15\/2019","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/212725s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/212725Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2019-08-15
)
)