Application Sponsors
ANDA 209024 | FRESENIUS KABI USA | |
Marketing Status
Application Products
001 | INJECTABLE;INJECTION | 0.2MG/ML | 0 | GLYCOPYRROLATE | GLYCOPYRROLATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2018-10-31 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
FRESENIUS KABI USA
cder:Array
(
[0] => Array
(
[ApplNo] => 209024
[companyName] => FRESENIUS KABI USA
[docInserts] => ["",""]
[products] => [{"drugName":"GLYCOPYRROLATE","activeIngredients":"GLYCOPYRROLATE","strength":"0.2MG\/ML","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/31\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2018-10-31
)
)