FDA.reportPublic FDA data

Application 021606

Type
NDA
Sponsor
ABBVIE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ZEMPLARPARICALCITOLCAPSULE;ORAL1MCGYesNo
002ZEMPLARPARICALCITOLCAPSULE;ORAL2MCGYesNo
003ZEMPLARPARICALCITOLCAPSULE;ORAL4MCG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0074-4314ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4314ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-4314ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9036ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
0074-9037ZemplarParicalcitolAbbVie Inc.NDACurrent
68382-266ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-266ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-267ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-267ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-330ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-330ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-330ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-330ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-330ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-331ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-331ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-331ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-331ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent
68382-331ParicalcitolParicalcitolZydus Pharmaceuticals USA IncNDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47276SUPPL2017-02-22
47275SUPPL2017-02-22
45564SUPPL2016-10-20
45563SUPPL2016-10-20
37332SUPPL2014-09-03
28238SUPPL2014-09-03
15865SUPPL2014-09-03
5840SUPPL2014-09-03
5838SUPPL2011-04-19
5839SUPPL2011-04-11
15864SUPPL2011-04-07
5837SUPPL2010-06-15
37331SUPPL2010-06-14
5836SUPPL2009-07-07
37330SUPPL2009-07-02
21757ORIG2007-01-26
28237ORIG2005-05-27
15863ORIG2005-05-27
51552ORIG1900-01-01
51551ORIG1900-01-01
51550ORIG1900-01-01
51549ORIG1900-01-01