ANDA 206964

ANI PHARMS INC

FDA Drug Application

Application #206964

Application Sponsors

ANDA 206964

ANI PHARMS INC

Marketing Status

• Discontinued: 001

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

ORIG	1	Null	7
SUPPL	7	Null	15

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
        )

)