Documents
Application Sponsors
| NDA 209115 | CLOVIS ONCOLOGY INC | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
| Prescription | 003 |
Application Products
| 001 | TABLET;ORAL | EQ 200MG BASE | 1 | RUBRACA | RUCAPARIB CAMSYLATE |
| 002 | TABLET;ORAL | EQ 300MG BASE | 1 | RUBRACA | RUCAPARIB CAMSYLATE |
| 003 | TABLET;ORAL | EQ 250MG BASE | 1 | RUBRACA | RUCAPARIB CAMSYLATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2016-12-19 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 3 | AP | 2018-04-06 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 4 | AP | 2020-05-15 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 8 | AP | 2020-10-08 | PRIORITY |
| LABELING; Labeling | SUPPL | 9 | AP | 2021-09-30 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 11 | AP | 2022-06-10 | PRIORITY |
| EFFICACY; Efficacy | SUPPL | 13 | AP | 2022-12-21 | PRIORITY |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 8 | Null | 6 |
| SUPPL | 9 | Null | 6 |
| SUPPL | 11 | Null | 7 |
| SUPPL | 13 | Null | 6 |
CDER Filings
CLOVIS ONCOLOGY INC
cder:Array
(
[0] => Array
(
[ApplNo] => 209115
[companyName] => CLOVIS ONCOLOGY INC
[docInserts] => ["",""]
[products] => [{"drugName":"RUBRACA","activeIngredients":"RUCAPARIB CAMSYLATE","strength":"EQ 200MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"},{"drugName":"RUBRACA","activeIngredients":"RUCAPARIB CAMSYLATE","strength":"EQ 300MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"RUBRACA","activeIngredients":"RUCAPARIB CAMSYLATE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"No"}]
[labels] => [{"actionDate":"05\/15\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209115s004lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209115s003lbl.pdf\"}]","notes":""},{"actionDate":"12\/19\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/209115s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"12\/19\/2016","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\\\/2016\\\/209115s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/209115Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/209115Orig1s000TOC.cfm\"}]","notes":">"}]
[supplements] => [{"actionDate":"05\/15\/2020","submission":"SUPPL-4","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/209115s004lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/209115Orig1s004ltr.pdf\"}]","notes":">"},{"actionDate":"04\/06\/2018","submission":"SUPPL-3","supplementCategories":"Efficacy-New Indication","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/209115s003lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2018\\\/209115Orig1s003ltr.pdf\"}]","notes":">"}]
[actionDate] => 2020-05-15
)
)