Documents
Application Sponsors
Marketing Status
None (Tentative Approval) | 001 |
Application Products
001 | INJECTABLE;INJECTION | 200UNITS/10ML(20UNITS/ML) | 0 | VASOPRESSIN | VASOPRESSIN |
FDA Submissions
UNKNOWN; | ORIG | 1 | TA | 2022-08-10 | STANDARD |
Submissions Property Types
CDER Filings
AMNEAL EU LTD
cder:Array
(
[0] => Array
(
[ApplNo] => 212945
[companyName] => AMNEAL EU LTD
[docInserts] => ["",""]
[products] => [{"drugName":"VASOPRESSIN","activeIngredients":"VASOPRESSIN","strength":"200UNITS\/10ML(20UNITS\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"08\/10\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2022-08-10
)
)