Application Sponsors
ANDA 206058 | ACCORD HLTHCARE | |
Marketing Status
Application Products
001 | INJECTABLE;INTRAVENOUS | EQ 3MG BASE/3ML | 0 | IBANDRONATE SODIUM | IBANDRONATE SODIUM |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2016-02-05 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ACCORD HLTHCARE
cder:Array
(
[0] => Array
(
[ApplNo] => 206058
[companyName] => ACCORD HLTHCARE
[docInserts] => ["",""]
[products] => [{"drugName":"IBANDRONATE SODIUM","activeIngredients":"IBANDRONATE SODIUM","strength":"EQ 3MG BASE\/3ML","dosageForm":"INJECTABLE;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"02\/05\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"12\/12\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-12-12
)
)