Documents
Application Sponsors
| NDA 212690 | JAZZ PHARMS INC | |
Marketing Status
Application Products
| 001 | SOLUTION;ORAL | 0.5MG/ML | 2 | XYWAV | CALCIUM;MAGNESIUM;POTASSIUM;SODIUM OXYBATES |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2020-07-21 | PRIORITY |
| REMS; REMS | SUPPL | 2 | AP | 2021-02-11 | N/A |
| LABELING; Labeling | SUPPL | 5 | AP | 2021-06-23 | STANDARD |
| EFFICACY; Efficacy | SUPPL | 6 | AP | 2021-08-12 | PRIORITY |
| REMS; REMS | SUPPL | 8 | AP | 2021-12-09 | N/A |
| REMS; REMS | SUPPL | 9 | AP | 2022-02-09 | N/A |
| LABELING; Labeling | SUPPL | 10 | AP | 2022-08-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 2 |
| SUPPL | 8 | Orphan | 5 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 7 |
CDER Filings
JAZZ PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 212690
[companyName] => JAZZ PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"XYWAV","activeIngredients":"CALCIUM;MAGNESIUM;POTASSIUM;SODIUM OXYBATES","strength":"0.5MG\/ML","dosageForm":"SOLUTION;ORAL","marketingStatus":"Prescription","te":"None","rld":"TBD","rs":"No"}]
[labels] => [{"actionDate":"07\/21\/2020","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212690s000lbl.pdf\"}]","notes":""}]
[originalApprovals] => [{"actionDate":"07\/21\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"PRIORITY; Orphan","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2020\\\/212690s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2020\\\/212690Orig1s000ltr.pdf\"}]","notes":">"}]
[supplements] =>
[actionDate] => 2020-07-21
)
)