Application Sponsors
ANDA 200674 | FRESENIUS KABI USA | |
Marketing Status
Prescription | 001 |
Prescription | 002 |
Prescription | 003 |
Application Products
001 | INJECTABLE;INJECTION | EQ 250MG/50ML (EQ 5MG/ML) | 0 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN |
002 | INJECTABLE;INJECTION | EQ 500MG/100ML (EQ 5MG/ML) | 0 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN |
003 | INJECTABLE;INJECTION | EQ 750MG/150ML (EQ 5MG/ML) | 0 | LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER | LEVOFLOXACIN |
FDA Submissions
N/A; Not Applicable | ORIG | 1 | AP | 2013-06-19 | |
LABELING; Labeling | SUPPL | 3 | AP | 2015-10-19 | STANDARD |
LABELING; Labeling | SUPPL | 4 | AP | 2019-04-24 | STANDARD |
LABELING; Labeling | SUPPL | 6 | AP | 2018-10-18 | STANDARD |
LABELING; Labeling | SUPPL | 8 | AP | 2019-05-03 | STANDARD |
Submissions Property Types
ORIG | 1 | Null | 19 |
SUPPL | 3 | Null | 15 |
SUPPL | 4 | Null | 15 |
SUPPL | 6 | Null | 15 |
SUPPL | 8 | Null | 15 |
TE Codes
001 | Prescription | AP |
002 | Prescription | AP |
003 | Prescription | AP |
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 200674
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 250MG\/50ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/100ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/150ML (EQ 5MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"06\/19\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2018","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/24\/2019","submission":"SUPPL-4","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/19\/2015","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-03
)
)