Documents
Application Sponsors
| NDA 208447 | GLAXOSMITHKLINE | |
Marketing Status
Application Products
| 001 | CAPSULE;ORAL | EQ 100MG BASE | 1 | ZEJULA | NIRAPARIB TOSYLATE |
FDA Submissions
| TYPE 1; Type 1 - New Molecular Entity | ORIG | 1 | AP | 2017-03-27 | PRIORITY |
| LABELING; Labeling | SUPPL | 12 | AP | 2020-02-26 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 14 | AP | 2019-10-23 | PRIORITY |
| LABELING; Labeling | SUPPL | 15 | AP | 2020-04-29 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 17 | AP | 2020-04-29 | PRIORITY |
| LABELING; Labeling | SUPPL | 18 | AP | 2020-05-29 | STANDARD |
| LABELING; Labeling | SUPPL | 19 | AP | 2021-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 20 | AP | 2021-03-03 | STANDARD |
| LABELING; Labeling | SUPPL | 22 | AP | 2021-07-27 | STANDARD |
| LABELING; Labeling | SUPPL | 24 | AP | 2021-07-27 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 25 | AP | 2022-12-08 | STANDARD |
| LABELING; Labeling | SUPPL | 26 | AP | 2022-09-14 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 10 |
| SUPPL | 12 | Null | 7 |
| SUPPL | 14 | Null | 6 |
| SUPPL | 15 | Null | 7 |
| SUPPL | 17 | Null | 6 |
| SUPPL | 18 | Null | 6 |
| SUPPL | 19 | Orphan | 5 |
| SUPPL | 20 | Orphan | 5 |
| SUPPL | 22 | Null | 6 |
| SUPPL | 24 | Null | 15 |
| SUPPL | 25 | Null | 6 |
| SUPPL | 26 | Null | 15 |
CDER Filings
GLAXOSMITHKLINE
cder:Array
(
[0] => Array
(
[ApplNo] => 208447
[companyName] => GLAXOSMITHKLINE
[docInserts] => ["",""]
[products] => [{"drugName":"ZEJULA","activeIngredients":"NIRAPARIB TOSYLATE","strength":"EQ 100MG BASE","dosageForm":"CAPSULE;ORAL","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"}]
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[originalApprovals] => [{"actionDate":"03\/27\/2017","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\\\/2017\\\/208447lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/208447Orig1s000Ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/208447_zejula_toc.cfm\"}]","notes":">"}]
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[actionDate] => 2020-05-29
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