Application Sponsors
| ANDA 203987 | EMCURE PHARMS LTD | |
Marketing Status
Application Products
| 001 | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | 0 | IBANDRONATE SODIUM | IBANDRONATE SODIUM |
FDA Submissions
| UNKNOWN; | ORIG | 1 | AP | 2014-09-02 | |
| LABELING; Labeling | SUPPL | 3 | AP | 2015-09-02 | STANDARD |
| LABELING; Labeling | SUPPL | 8 | AP | 2019-12-17 | STANDARD |
Submissions Property Types
| ORIG | 1 | Null | 15 |
| SUPPL | 3 | Null | 7 |
| SUPPL | 8 | Null | 7 |
CDER Filings
EMCURE PHARMS LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 203987
[companyName] => EMCURE PHARMS LTD
[docInserts] => ["",""]
[products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 3MG BASE\/3ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"09\/02\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/17\/2019","submission":"SUPPL-8","supplementCategories":"Labeling-Container\/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"09\/02\/2015","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-17
)
)