FDA.reportPublic FDA data

Application 020819

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEMPLARPARICALCITOLSOLUTION;INTRAVENOUS0.005MG/ML (0.005MG/ML)YesYes
002ZEMPLARPARICALCITOLSOLUTION;INTRAVENOUS0.002MG/ML (0.002MG/ML)YesYes
003ZEMPLARPARICALCITOLSOLUTION;INTRAVENOUS0.01MG/2ML (0.005MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-1658ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4637ZemplarParicalcitolAbbVie Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72466SUPPL2022-10-26
72435SUPPL2022-10-21
68383SUPPL2021-08-16
68353SUPPL2021-08-12
66477SUPPL2021-03-03
66462SUPPL2021-03-03
56724SUPPL2018-12-12
56551SUPPL2018-11-23
3416SUPPL2011-04-11
35412SUPPL2011-04-07
25913SUPPL2011-02-04
25912SUPPL2009-11-19
35411SUPPL2009-09-17
13483SUPPL2005-09-08
3415SUPPL2005-09-08
25911SUPPL2004-04-07
13482SUPPL2004-04-05
25910SUPPL2003-03-10
3414SUPPL2003-03-10
13481SUPPL2000-02-02
3413SUPPL2000-02-02
35410ORIG1998-04-17
25909ORIG1998-04-17
20975ORIG1998-04-17
66776ORIG1900-01-01
66774ORIG1900-01-01
52160ORIG1900-01-01
52159ORIG1900-01-01
52158ORIG1900-01-01
52157ORIG1900-01-01