Application Sponsors
ANDA 206964 | ANI PHARMS INC | |
Marketing Status
Application Products
001 | CAPSULE, EXTENDED RELEASE;ORAL | 25MG;200MG | 0 | ASPIRIN AND DIPYRIDAMOLE | ASPIRIN; DIPYRIDAMOLE |
FDA Submissions
UNKNOWN; | ORIG | 1 | AP | 2017-01-18 | STANDARD |
LABELING; Labeling | SUPPL | 7 | AP | 2019-04-16 | STANDARD |
Submissions Property Types
CDER Filings
ANI PHARMS INC
cder:Array
(
[0] => Array
(
[ApplNo] => 206964
[companyName] => ANI PHARMS INC
[docInserts] => ["",""]
[products] => [{"drugName":"ASPIRIN AND DIPYRIDAMOLE","activeIngredients":"ASPIRIN; DIPYRIDAMOLE","strength":"25MG;200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
[labels] =>
[originalApprovals] => [{"actionDate":"01\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
[supplements] => [{"actionDate":"04\/16\/2019","submission":"SUPPL-7","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
[actionDate] => 2019-04-16
)
)