ANDA 204052

SANDOZ INC

FDA Drug Application

Application #204052

Application Sponsors

ANDA 204052

SANDOZ INC

Marketing Status

• Prescription: 001

Application Products

001

SOLUTION;INTRAVENOUS

1GM/100ML (10MG/ML)

0

ACETAMINOPHEN

ACETAMINOPHEN

FDA Submissions

UNKNOWN;	ORIG	1	AP	2016-03-22
LABELING; Labeling	SUPPL	2	AP	2020-07-24	STANDARD

Submissions Property Types

ORIG	1	Null	15
SUPPL	2	Null	15

TE Codes

001

Prescription

AP

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 204052
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"ACETAMINOPHEN","activeIngredients":"ACETAMINOPHEN","strength":"1GM\/100ML (10MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/22\/2016","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"07\/24\/2020","submission":"SUPPL-2","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"10\/31\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2020-07-24
        )

)