ANDA 208572

SUN PHARM

FDA Drug Application

Application #208572

Application Sponsors

ANDA 208572

SUN PHARM

Marketing Status

• Prescription: 001

Application Products

001

CAPSULE, EXTENDED RELEASE;ORAL

25MG;200MG

0

ASPIRIN AND DIPYRIDAMOLE

ASPIRIN; DIPYRIDAMOLE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2018-08-21

STANDARD

Submissions Property Types

ORIG

1

Null

31

TE Codes

001

Prescription

AB

CDER Filings

SUN PHARM

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 208572
            [companyName] => SUN PHARM
            [docInserts] => ["",""]
            [products] => [{"drugName":"ASPIRIN AND DIPYRIDAMOLE","activeIngredients":"ASPIRIN; DIPYRIDAMOLE","strength":"25MG;200MG","dosageForm":"CAPSULE, EXTENDED RELEASE;ORAL","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/21\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"04\/02\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-04-02
        )

)