ANDA 214311

SANDOZ INC

FDA Drug Application

Application #214311

Application Sponsors

ANDA 214311

SANDOZ INC

Marketing Status

• None (Tentative Approval): 001
• None (Tentative Approval): 002

Application Products

002

SOLUTION;INTRAVENOUS

EQ 500MG BASE/5ML (EQ 100MG BASE/ML)

0

SUGAMMADEX SODIUM

SUGAMMADEX SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-03-08

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

SANDOZ INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 214311
            [companyName] => SANDOZ INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUGAMMADEX SODIUM","activeIngredients":"SUGAMMADEX SODIUM","strength":"EQ 200MG BASE\/2ML (EQ 100MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUGAMMADEX SODIUM","activeIngredients":"SUGAMMADEX SODIUM","strength":"EQ 500MG BASE\/5ML (EQ 100MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"03\/08\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-03-08
        )

)