Application Sponsors
| ANDA 202590 | EMCURE PHARMS LTD | |
Marketing Status
| Discontinued | 001 |
| Discontinued | 002 |
Application Products
| 001 | INJECTABLE;INJECTION | EQ 500MG/20ML (EQ 25MG/ML) | 0 | LEVOFLOXACIN | LEVOFLOXACIN |
| 002 | INJECTABLE;INJECTION | EQ 750MG/30ML (EQ 25MG/ML) | 0 | LEVOFLOXACIN | LEVOFLOXACIN |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2013-01-24 | |
| LABELING; Labeling | SUPPL | 2 | AP | 2016-07-14 | STANDARD |
| LABELING; Labeling | SUPPL | 6 | AP | 2019-04-17 | STANDARD |
| LABELING; Labeling | SUPPL | 9 | AP | 2018-10-18 | STANDARD |
| LABELING; Labeling | SUPPL | 10 | AP | 2019-05-03 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 2 | Null | 7 |
| SUPPL | 6 | Null | 7 |
| SUPPL | 9 | Null | 15 |
| SUPPL | 10 | Null | 7 |
CDER Filings
EMCURE PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 202590
[companyName] => EMCURE PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 500MG\/20ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"LEVOFLOXACIN","activeIngredients":"LEVOFLOXACIN","strength":"EQ 750MG\/30ML (EQ 25MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/24\/2013","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"05\/03\/2019","submission":"SUPPL-10","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/18\/2018","submission":"SUPPL-9","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"04\/17\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/14\/2016","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert, Labeling-Medication Guide","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"07\/14\/2016","submission":"SUPPL-1","supplementCategories":"Labeling-Medication Guide, Labeling-Package Insert, Labeling-Container\/Carton Labels","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-05-03
)
)