ANDA 200833

JIANGSU HENGRUI MED

FDA Drug Application

Application #200833

Application Sponsors

ANDA 200833

JIANGSU HENGRUI MED

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

N/A; Not Applicable	ORIG	1	AP	2018-06-28
LABELING; Labeling	SUPPL	3	AP	2019-08-02	STANDARD

Submissions Property Types

ORIG	1	Null	42
SUPPL	3	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 200833
            [companyName] => JIANGSU HENGRUI MED
            [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":"06\/28\/2018","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Not Applicable","reviewPriority":"","inserts":"[]","notes":"> Label is not available on this site."}]
            [supplements] => [{"actionDate":"08\/02\/2019","submission":"SUPPL-3","supplementCategories":"Labeling","inserts":"[]","notes":"> Label is not available on this site."}]
            [actionDate] => 2019-08-02
        )

)