ANDA 209048

DR REDDYS

FDA Drug Application

Application #209048

Application Sponsors

ANDA 209048

DR REDDYS

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	2018-10-10	STANDARD
LABELING; Labeling	SUPPL	2	AP	2021-10-06	STANDARD
LABELING; Labeling	SUPPL	5	AP	2021-10-06	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	7
SUPPL	5	Null	15

TE Codes

001

Prescription

AB

CDER Filings

DR REDDYS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209048
            [companyName] => DR REDDYS
            [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":"10\/10\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"03\/10\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert, Labeling-Patient Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-03-10
        )

)