NDA 205917

HIKMA PHARMS

FDA Drug Application

Application #205917

Documents

• Review: 2015-01-29
• Letter: 2014-11-19
• Label: 2014-11-20

Application Sponsors

NDA 205917

HIKMA PHARMS

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	0.002MG/ML (0.002MG/ML)	0	PARICALCITOL	PARICALCITOL
002	SOLUTION;INTRAVENOUS	0.005MG/ML (0.005MG/ML)	0	PARICALCITOL	PARICALCITOL
003	SOLUTION;INTRAVENOUS	0.01MG/2ML (0.005MG/ML)	0	PARICALCITOL	PARICALCITOL

FDA Submissions

TYPE 5; Type 5 - New Formulation or New Manufacturer

ORIG

1

AP

2014-11-18

STANDARD

Submissions Property Types

ORIG

1

Null

40

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

HIKMA PHARMS

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 205917
            [companyName] => HIKMA PHARMS
            [docInserts] => ["",""]
            [products] => [{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"0.002MG\/ML (0.002MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"0.005MG\/ML (0.005MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"},{"drugName":"PARICALCITOL","activeIngredients":"PARICALCITOL","strength":"0.01MG\/2ML (0.005MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"No","rs":"No"}]
            [labels] => [{"actionDate":"11\/18\/2014","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205917s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"11\/18\/2014","submission":"ORIG-1","actionType":"Approval","submissionClassification":"Type 5 - New Formulation or New Manufacturer","reviewPriority":"STANDARD","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2014\\\/205917s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2014\\\/205917Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2014\\\/205917Orig1s000TOC.cfm\"}]","notes":">"}]
            [supplements] => 
            [actionDate] => 2014-11-18
        )

)