ANDA 213915

MYLAN PHARMS INC

FDA Drug Application

Application #213915

Documents

• Letter: 2022-12-20

Application Sponsors

ANDA 213915

MYLAN PHARMS INC

Marketing Status

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

Application Products

001	INJECTABLE;INJECTION	200MG/2ML(100MG/ML)	0	SUGAMMADEX	SUGAMMADEX SODIUM
002	INJECTABLE;INJECTION	500MG/5ML(100MG/ML)	0	SUGAMMADEX	SUGAMMADEX SODIUM

FDA Submissions

UNKNOWN;

ORIG

1

TA

2022-10-13

STANDARD

Submissions Property Types

ORIG

1

Null

31

CDER Filings

MYLAN PHARMS INC

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 213915
            [companyName] => MYLAN PHARMS INC
            [docInserts] => ["",""]
            [products] => [{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX SODIUM","strength":"200MG\/2ML(100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"},{"drugName":"SUGAMMADEX","activeIngredients":"SUGAMMADEX SODIUM","strength":"500MG\/5ML(100MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"None (Tentative Approval)","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"10\/13\/2022","submission":"ORIG-1","actionType":"Tentative Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2022-10-13
        )

)