Application Sponsors
| ANDA 204125 | XELLIA PHARMS APS | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 5GM BASE/VIAL | 0 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
| 002 | INJECTABLE;INJECTION | EQ 10GM BASE/VIAL | 0 | VANCOMYCIN HYDROCHLORIDE | VANCOMYCIN HYDROCHLORIDE |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2015-12-28 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2018-08-01 | STANDARD |
| LABELING; Labeling | SUPPL | 11 | AP | 2021-09-24 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 7 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 11 | Null | 7 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
XELLIA PHARMS APS
cder:Array
(
[0] => Array
(
[ApplNo] => 204125
[companyName] => XELLIA PHARMS APS
[docInserts] => ["",""]
[products] => [{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"VANCOMYCIN HYDROCHLORIDE","activeIngredients":"VANCOMYCIN HYDROCHLORIDE","strength":"EQ 10GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/28\/2015","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"08\/01\/2018","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2018-08-01
)
)