ANDA 209489

CIPLA

FDA Drug Application

Application #209489

Application Sponsors

ANDA 209489

CIPLA

Marketing Status

• Discontinued: 001
• Discontinued: 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

2018-07-12

STANDARD

Submissions Property Types

ORIG

1

Null

7

CDER Filings

CIPLA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209489
            [companyName] => CIPLA
            [docInserts] => ["",""]
            [products] => [{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"50MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CASPOFUNGIN ACETATE","activeIngredients":"CASPOFUNGIN ACETATE","strength":"70MG\/VIAL","dosageForm":"POWDER;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"07\/12\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"10\/10\/2019","submission":"SUPPL-1","supplementCategories":"Labeling-Package Insert","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-10-10
        )

)