Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | SOLUTION;INTRAVENOUS | 0.5MG/5ML (0.1MG/ML) | 0 | ATROPINE SULFATE | ATROPINE SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2021-10-26 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
AMNEAL EU LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 215342
[companyName] => AMNEAL EU LTD
[docInserts] => ["",""]
[products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"UNKNOWN","dosageForm":"UNKNOWN","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/26\/2021","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2021-10-26
)
)