Application Sponsors
| ANDA 076757 | HIKMA FARMACEUTICA | |
Marketing Status
Application Products
| 001 | INJECTABLE;INJECTION | 200MG/100ML | 0 | CIPROFLOXACIN IN DEXTROSE 5% | CIPROFLOXACIN |
FDA Submissions
| ORIG | 1 | AP | 2008-04-21 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2011-06-23 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2014-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2018-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2018-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-04-18 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2019-05-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 1 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
| SUPPL | 8 | Null | 15 |
| SUPPL | 9 | Null | 7 |
CDER Filings
HIKMA FARMACEUTICA
cder:Array
(
[0] => Array
(
[ApplNo] => 76757
[companyName] => HIKMA FARMACEUTICA
[docInserts] => ["",""]
[products] => [{"drugName":"CIPROFLOXACIN IN DEXTROSE 5%","activeIngredients":"CIPROFLOXACIN","strength":"200MG\/100ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CIPROFLOXACIN IN DEXTROSE 5%","submission":"CIPROFLOXACIN","actionType":"200MG\/100ML","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)