SANDOZ INC FDA Approval ANDA 203557

ANDA 203557

SANDOZ INC

FDA Drug Application

Application #203557

Application Sponsors

ANDA 203557SANDOZ INC

Marketing Status

Prescription001
Prescription002

Application Products

001INJECTABLE;INJECTIONEQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL0PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUM
002INJECTABLE;INJECTIONEQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL0PIPERACILLIN AND TAZOBACTAMPIPERACILLIN SODIUM; TAZOBACTAM SODIUM

FDA Submissions

UNKNOWN; ORIG1AP2014-10-29
MANUF (CMC); Manufacturing (CMC)SUPPL3AP2016-03-24UNKNOWN
LABELING; LabelingSUPPL11AP2019-08-30STANDARD
LABELING; LabelingSUPPL17AP2019-08-30STANDARD
LABELING; LabelingSUPPL22AP2021-07-08STANDARD
LABELING; LabelingSUPPL24AP2021-12-08STANDARD

Submissions Property Types

ORIG1Null1
SUPPL3Null15
SUPPL11Null15
SUPPL17Null7
SUPPL22Null15
SUPPL24Null15

TE Codes

001PrescriptionAP
002PrescriptionAP

CDER Filings

SANDOZ INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 203557
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"PIPERACILLIN AND TAZOBACTAM","activeIngredients":"PIPERACILLIN SODIUM; TAZOBACTAM SODIUM","strength":"EQ 12GM BASE\/VIAL;EQ 1.5GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/29\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/30\/2019","submission":"SUPPL-17","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"08\/30\/2019","submission":"SUPPL-11","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."},{"actionDate":"03\/24\/2016","submission":"SUPPL-3","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-30
        )

)

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