FDA.reportPublic FDA data

Application 021027

Type
NDA
Sponsor
SANOFI

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001HECTOROLDOXERCALCIFEROLINJECTABLE;INJECTION4MCG/2ML (2MCG/ML)YesYes
002HECTOROLDOXERCALCIFEROLINJECTABLE;INJECTION2MCG/ML (2MCG/ML)YesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
58468-0123HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0123HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0123HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0123HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0126HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0126HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0127HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0127HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0127HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent
58468-0127HectorolDOXERCALCIFEROLGenzyme CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
72401SUPPL2022-10-17
72181SUPPL2022-09-29
56749SUPPL2018-12-14
56550SUPPL2018-11-23
26526SUPPL2016-06-06
14196SUPPL2016-06-02
21361SUPPL2012-05-09
35928SUPPL2009-01-02
4089SUPPL2008-12-11
14195SUPPL2006-07-21
4088SUPPL2006-07-21
35927SUPPL2005-06-23
26525SUPPL2005-06-23
4087SUPPL2003-12-04
35926ORIG2000-04-06
26524ORIG2000-04-06
21360ORIG2000-04-06