NDA 020819

ABBVIE

FDA Drug Application

Application #020819

Documents

• Letter: 2000-02-02
• Letter: 2003-03-10
• Letter: 2005-09-08
• Letter: 2011-04-11
• Label: 2000-02-02
• Label: 2004-04-05
• Label: 2005-09-08
• Review: 1998-04-17
• Letter: 1998-04-17
• Letter: 2003-03-10
• Letter: 2004-04-07
• Letter: 2009-11-19
• Letter: 2011-02-04
• Label: 1998-04-17
• Label: 2009-09-17
• Label: 2011-04-07
• Pediatric Written Request: 1900-01-01
• Pediatric Reissue Amendment 1: 1900-01-01
• Pediatric Medical Review: 1900-01-01
• Pediatric Statistical Review: 1900-01-01
• Label: 2018-11-23
• Letter: 2018-12-12
• Letter: 2021-03-03
• Label: 2021-03-03
• Pediatric CDTL Review: 1900-01-01
• Pediatric Clinical Pharmacology Review: 1900-01-01
• Letter: 2021-08-12
• Label: 2021-08-16
• Letter: 2022-10-21
• Label: 2022-10-26

Application Sponsors

NDA 020819

ABBVIE

Marketing Status

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

Application Products

001	SOLUTION;INTRAVENOUS	0.005MG/ML (0.005MG/ML)	1	ZEMPLAR	PARICALCITOL
002	SOLUTION;INTRAVENOUS	0.002MG/ML (0.002MG/ML)	1	ZEMPLAR	PARICALCITOL
003	SOLUTION;INTRAVENOUS	0.01MG/2ML (0.005MG/ML)	1	ZEMPLAR	PARICALCITOL

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1998-04-17	STANDARD
EFFICACY; Efficacy	SUPPL	3	AP	2000-02-02	UNKNOWN
LABELING; Labeling	SUPPL	4	AP	2000-09-13	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	5	AP	1999-10-18	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	6	AP	2000-02-01	STANDARD
LABELING; Labeling	SUPPL	7	AP	2003-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	9	AP	2002-01-08	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	10	AP	2002-01-25	STANDARD
LABELING; Labeling	SUPPL	11	AP	2003-02-24	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	12	AP	2002-12-06	STANDARD
EFFICACY; Efficacy	SUPPL	14	AP	2004-03-31	PRIORITY
LABELING; Labeling	SUPPL	15	AP	2005-09-02	STANDARD
LABELING; Labeling	SUPPL	21	AP	2009-08-20	STANDARD
LABELING; Labeling	SUPPL	24	AP	2011-02-01	UNKNOWN
LABELING; Labeling	SUPPL	25	AP	2011-04-06	UNKNOWN
LABELING; Labeling	SUPPL	30	AP	2018-11-21	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	31	AP	2013-07-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	32	AP	2016-11-30	STANDARD
LABELING; Labeling	SUPPL	36	AP	2021-03-02	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	37	AP	2021-05-12	N/A
LABELING; Labeling	SUPPL	38	AP	2022-10-20	STANDARD

Submissions Property Types

SUPPL	5	Null	0
SUPPL	6	Null	0
SUPPL	9	Null	0
SUPPL	10	Null	0
SUPPL	12	Null	0
SUPPL	14	Null	26
SUPPL	21	Null	6
SUPPL	24	Null	7
SUPPL	25	Null	6
SUPPL	30	Null	15
SUPPL	31	Null	0
SUPPL	36	Null	7
SUPPL	38	Orphan	5

TE Codes

001	Prescription	AP
002	Prescription	AP
003	Prescription	AP

CDER Filings

ABBVIE

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 20819
            [companyName] => ABBVIE
            [docInserts] => ["",""]
            [products] => [{"drugName":"ZEMPLAR","activeIngredients":"PARICALCITOL","strength":"0.005MG\/ML (0.005MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZEMPLAR","activeIngredients":"PARICALCITOL","strength":"0.002MG\/ML (0.002MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"},{"drugName":"ZEMPLAR","activeIngredients":"PARICALCITOL","strength":"0.01MG\/2ML (0.005MG\/ML)","dosageForm":"SOLUTION;INTRAVENOUS","marketingStatus":"Prescription","te":"","rld":"Yes","rs":"Yes"}]
            [labels] => [{"actionDate":"11\/21\/2018","submission":"SUPPL-30","supplementCategories":"Labeling-Package Insert","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2018\\\/020819s030lbl.pdf\"}]","notes":""},{"actionDate":"04\/06\/2011","submission":"SUPPL-25","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2011\\\/020819s025lbl.pdf\"}]","notes":""},{"actionDate":"08\/20\/2009","submission":"SUPPL-21","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2009\\\/020819s021lbl.pdf\"}]","notes":""},{"actionDate":"09\/02\/2005","submission":"SUPPL-15","supplementCategories":"Labeling","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2005\\\/020819s015lbl.pdf\"}]","notes":""},{"actionDate":"03\/31\/2004","submission":"SUPPL-14","supplementCategories":"Efficacy-New Patient Population","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2004\\\/20819se5-014_zemplar_lbl.pdf\"}]","notes":""},{"actionDate":"02\/02\/2000","submission":"SUPPL-3","supplementCategories":"Efficacy-Labeling Change With Clinical Data","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/2000\\\/20819S3LBL.PDF\"}]","notes":""},{"actionDate":"04\/17\/1998","submission":"ORIG-1","supplementCategories":"Approval","inserts":"[{\"name\":\"Label (PDF)\",\"url\":\"https:\\\/\\\/www.accessdata.fda.gov\\\/drugsatfda_docs\\\/label\\\/1998\\\/20819lbl.pdf\"}]","notes":""}]
            [originalApprovals] => [{"actionDate":"ZEMPLAR","submission":"PARICALCITOL","actionType":"0.005MG\/ML (0.005MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZEMPLAR","submission":"PARICALCITOL","actionType":"0.002MG\/ML (0.002MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"},{"actionDate":"ZEMPLAR","submission":"PARICALCITOL","actionType":"0.01MG\/2ML (0.005MG\/ML)","submissionClassification":"SOLUTION;INTRAVENOUS","reviewPriority":"Prescription","inserts":"[]","notes":">Yes"}]
            [supplements] => 
            [actionDate] => 2018-11-21
        )

)