Application Sponsors
| ANDA 202253 | FRESENIUS KABI USA | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | EQ 2MG BASE/ML | 0 | ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE | ONDANSETRON HYDROCHLORIDE |
FDA Submissions
| ORIG | 1 | AP | 2013-07-19 | |
| LABELING; Labeling | SUPPL | 4 | AP | 2015-10-22 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2015-11-16 | |
| LABELING; Labeling | SUPPL | 7 | AP | 2015-10-22 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 4 | Null | 7 |
| SUPPL | 5 | Null | 15 |
| SUPPL | 7 | Null | 15 |
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 202253
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE","activeIngredients":"ONDANSETRON HYDROCHLORIDE","strength":"EQ 2MG BASE\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"07\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"10\/22\/2015","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"11\/16\/2015","submission":"SUPPL-5","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/22\/2015","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/09\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2015-11-16
)
)