HOSPIRA INC FDA Approval ANDA 090375

ANDA 090375

HOSPIRA INC

FDA Drug Application

Application #090375

Application Sponsors

ANDA 090375HOSPIRA INC

Marketing Status

Discontinued001
Discontinued002

Application Products

001INJECTABLE;INJECTIONEQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL0AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUM
002INJECTABLE;INJECTIONEQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL0AMPICILLIN AND SULBACTAMAMPICILLIN SODIUM; SULBACTAM SODIUM

FDA Submissions

ORIG1AP2011-12-21
LABELING; LabelingSUPPL3AP2015-09-02STANDARD

Submissions Property Types

ORIG1Null15
SUPPL3Null15

CDER Filings

HOSPIRA INC
cder:Array
(
    [0] => Array
        (
            [ApplNo] => 90375
            [companyName] => HOSPIRA INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"AMPICILLIN AND SULBACTAM","activeIngredients":"AMPICILLIN SODIUM; SULBACTAM SODIUM","strength":"EQ 1GM BASE\/VIAL;EQ 500MG BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"AMPICILLIN AND SULBACTAM","activeIngredients":"AMPICILLIN SODIUM; SULBACTAM SODIUM","strength":"EQ 2GM BASE\/VIAL;EQ 1GM BASE\/VIAL","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"AMPICILLIN AND SULBACTAM","submission":"AMPICILLIN SODIUM; SULBACTAM SODIUM","actionType":"EQ 1GM BASE\/VIAL;EQ 500MG BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"AMPICILLIN AND SULBACTAM","submission":"AMPICILLIN SODIUM; SULBACTAM SODIUM","actionType":"EQ 2GM BASE\/VIAL;EQ 1GM BASE\/VIAL","submissionClassification":"INJECTABLE;INJECTION","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)

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