ANDA 206739

SANDOZ INC

FDA Drug Application

Application #206739

Application Sponsors

ANDA 206739

SANDOZ INC

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	2017-01-18	STANDARD
LABELING; Labeling	SUPPL	2	AP	2020-11-10	STANDARD
LABELING; Labeling	SUPPL	4	AP	2022-01-19	STANDARD

Submissions Property Types

ORIG	1	Null	7
SUPPL	2	Null	7
SUPPL	4	Null	15

TE Codes

001

Prescription

AB

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 206739
            [companyName] => SANDOZ INC
            [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":"01\/18\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-01-18
        )

)