Documents
Application Sponsors
ANDA 212461 | INTL MEDICATION SYS | |
Marketing Status
Application Products
001 | SOLUTION;INTRAVENOUS | 1MG/10ML (0.1MG/ML) | 0 | ATROPINE SULFATE | ATROPINE SULFATE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-10-06 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
INTL MEDICATION SYS
cder:Array
(
[0] => Array
(
[ApplNo] => 212461
[companyName] => INTL MEDICATION SYS
[docInserts] => ["",""]
[products] => [{"drugName":"ATROPINE SULFATE","activeIngredients":"ATROPINE SULFATE","strength":"1MG\/10ML (0.1MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"10\/06\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-10-06
)
)