Application Sponsors
| ANDA 076717 | HIKMA FARMACEUTICA | |
Marketing Status
| Prescription | 001 |
| Prescription | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | 200MG/20ML (10MG/ML) | 0 | CIPROFLOXACIN | CIPROFLOXACIN |
| 002 | INJECTABLE;INJECTION | 400MG/40ML (10MG/ML) | 0 | CIPROFLOXACIN | CIPROFLOXACIN |
FDA Submissions
| ORIG | 1 | AP | 2009-12-22 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2014-06-25 | STANDARD |
| LABELING; Labeling | SUPPL | 3 | AP | 2018-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 4 | AP | 2018-10-15 | STANDARD |
| LABELING; Labeling | SUPPL | 5 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-04-16 | STANDARD |
| LABELING; Labeling | SUPPL | 7 | AP | 2019-05-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 42 |
| SUPPL | 2 | Null | 15 |
| SUPPL | 3 | Null | 15 |
| SUPPL | 4 | Null | 15 |
| SUPPL | 5 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 7 | Null | 15 |
TE Codes
| 001 | Prescription | AP |
| 002 | Prescription | AP |
CDER Filings
HIKMA FARMACEUTICA
cder:Array
(
[0] => Array
(
[ApplNo] => 76717
[companyName] => HIKMA FARMACEUTICA
[docInserts] => ["",""]
[products] => [{"drugName":"CIPROFLOXACIN","activeIngredients":"CIPROFLOXACIN","strength":"200MG\/20ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN","activeIngredients":"CIPROFLOXACIN","strength":"400MG\/40ML (10MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"CIPROFLOXACIN","submission":"CIPROFLOXACIN","actionType":"200MG\/20ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN","submission":"CIPROFLOXACIN","actionType":"400MG\/40ML (10MG\/ML)","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Prescription","inserts":"[]","notes":">No"}]
[supplements] =>
[actionDate] => 1969-12-31
)
)