NDA 209360

LA JOLLA PHARMA

FDA Drug Application

Application #209360

Documents

• Label: 2017-12-26
• Letter: 2017-12-27
• Review: 2018-01-31

Application Sponsors

NDA 209360

LA JOLLA PHARMA

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	EQ 2.5MG BASE/ML (EQ 2.5MG BASE/ML)	1	GIAPREZA	ANGIOTENSIN II ACETATE
002	SOLUTION;INTRAVENOUS	EQ 5MG BASE/2ML (EQ 2.5MG BASE/ML)	1	GIAPREZA	ANGIOTENSIN II ACETATE
003	SOLUTION;INTRAVENOUS	EQ 0.5MG BASE/ML (EQ 0.5MG BASE/ML)	1	GIAPREZA	ANGIOTENSIN II ACETATE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity

ORIG

1

AP

2017-12-21

PRIORITY

Submissions Property Types

ORIG

1

Null

15

CDER Filings

LA JOLLA PHARMA

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 209360
            [companyName] => LA JOLLA PHARMA
            [docInserts] => ["",""]
            [products] => [{"drugName":"GIAPREZA","activeIngredients":"ANGIOTENSIN II ACETATE","strength":"EQ 2.5MG BASE\/ML (EQ 2.5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"None","rld":"Yes","rs":"Yes"},{"drugName":"GIAPREZA","activeIngredients":"ANGIOTENSIN II ACETATE","strength":"EQ 5MG BASE\/2ML (EQ 2.5MG BASE\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Discontinued","te":"None","rld":"Yes","rs":"No"}]
            [labels] => [{"actionDate":"12\/21\/2017","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209360s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"12\/21\/2017","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 1 - New Molecular Entity","reviewPriority":"PRIORITY","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2017\\\/209360s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2017\\\/209360Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2017\\\/209360Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2017-12-21
        )

)