ANDA 207252

JIANGSU HENGRUI MED

FDA Drug Application

Application #207252

Documents

• Letter: 2017-09-07

Application Sponsors

ANDA 207252

JIANGSU HENGRUI MED

Marketing Status

• Prescription: 001
• Prescription: 002
• Prescription: 003

Application Products

001	INJECTABLE;INJECTION	20MG/ML (20MG/ML)	0	DOCETAXEL	DOCETAXEL
002	INJECTABLE;INJECTION	80MG/4ML (20MG/ML)	0	DOCETAXEL	DOCETAXEL
003	INJECTABLE;INJECTION	160MG/8ML (20MG/ML)	0	DOCETAXEL	DOCETAXEL

FDA Submissions

UNKNOWN;

ORIG

1

AP

2017-08-09

STANDARD

Submissions Property Types

ORIG

1

Null

7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

JIANGSU HENGRUI MED

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207252
            [companyName] => JIANGSU HENGRUI MED
            [docInserts] => ["",""]
            [products] => [{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"20MG\/ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"80MG\/4ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"DOCETAXEL","activeIngredients":"DOCETAXEL","strength":"160MG\/8ML (20MG\/ML)","dosageForm":"INJECTABLE;INJECTION","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"08\/09\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/207252Orig1s000ltr.pdf\"}]","notes":"> Label is not available on this site."}]
            [supplements] => 
            [actionDate] => 2017-08-09
        )

)