NDA 207174

ACCORD HLTHCARE

FDA Drug Application

Application #207174

Documents

• Label: 2016-03-04
• Letter: 2016-02-09
• Review: 2016-12-06
• Summary Review: 2016-12-06
• Label: 2019-10-18
• Letter: 2019-10-18

Application Sponsors

NDA 207174

ACCORD HLTHCARE

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	2016-02-04	STANDARD
LABELING; Labeling	SUPPL	6	AP	2019-10-17	STANDARD

Submissions Property Types

ORIG	1	Null	6
SUPPL	6	Null	7

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ACCORD HLTHCARE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 207174
            [companyName] => ACCORD HLTHCARE
            [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":"10\/17\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207174s006lbl.pdf\"}]","notes":""},{"actionDate":"02\/04\/2016","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2016\\\/207174s000lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"02\/04\/2016","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\\\/2016\\\/207174s000lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2016\\\/207174Orig1s000ltr.pdf\"},{\"name\":\"Review\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207174Orig1s000TOC.cfm\"},{\"name\":\"Summary Review (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/nda\\\/2016\\\/207174Orig1s000SumR.pdf\"}]","notes":">"}]
            [supplements] => [{"actionDate":"10\/17\/2019","submission":"SUPPL-6","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2019\\\/207174s006lbl.pdf\"},{\"name\":\"Letter (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/appletter\\\/2019\\\/207174Orig1s006ltr.pdf\"}]","notes":">"}]
            [actionDate] => 2019-10-17
        )

)