Application Sponsors
ANDA 211629 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | UNKNOWN | UNKNOWN | 0 | AMINOCAPROIC ACID | AMINOCAPROIC ACID |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2020-12-14 | STANDARD |
Submissions Property Types
TE Codes
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 211629
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"AMINOCAPROIC ACID","activeIngredients":"AMINOCAPROIC ACID","strength":"500MG","dosageForm":"TABLET;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"12\/14\/2020","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] =>
[actionDate] => 2020-12-14
)
)