ANDA 207650

MYLAN LABS LTD

FDA Drug Application

Application #207650

Application Sponsors

ANDA 207650

MYLAN LABS LTD

Marketing Status

• Prescription: 001
• Prescription: 002

Application Products

001	POWDER;INTRAVENOUS	50MG/VIAL	0	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE
002	POWDER;INTRAVENOUS	70MG/VIAL	0	CASPOFUNGIN ACETATE	CASPOFUNGIN ACETATE

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-09-29

STANDARD

Submissions Property Types

ORIG

1

Null

15

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

MYLAN LABS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207650
            [companyName] => MYLAN LABS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"70MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"09\/29\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-09-29
        )

)