FDA.reportPublic FDA data

Application 020873

Type
NDA
Sponsor
SANDOZ INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ANGIOMAXBIVALIRUDININJECTABLE;INTRAVENOUS250MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3158bivalirudinbivalirudinSandozNDA AUTHORIZED GENERICCurrent
0781-3158bivalirudinbivalirudinSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3447AngiomaxbivalirudinSandoz IncNDACurrent
0781-3447AngiomaxbivalirudinSandoz IncNDACurrent
0781-9158bivalirudinbivalirudinSandoz IncNDA AUTHORIZED GENERICCurrent
0781-9158bivalirudinbivalirudinSandozNDA AUTHORIZED GENERICCurrent
65293-001AngiomaxbivalirudinThe Medicines CompanyNDACurrent
65293-001AngiomaxbivalirudinThe Medicines CompanyNDACurrent
65293-001AngiomaxbivalirudinThe Medicines CompanyNDACurrent
72572-035bivalirudinbivalirudinCivica, Inc.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59293SUPPL2019-07-10
59235SUPPL2019-07-05
57005SUPPL2018-12-26
35559SUPPL2016-03-22
26109SUPPL2016-03-22
26108SUPPL2013-05-22
35558SUPPL2013-05-21
35557SUPPL2010-07-01
3634SUPPL2010-06-29
35556SUPPL2005-12-05
26107SUPPL2005-12-05
3633SUPPL2005-09-08
26105SUPPL2005-06-15
26106SUPPL2004-05-07
21038ORIG2004-04-08
3632SUPPL2002-06-20
26104ORIG2000-12-15
13658ORIG2000-12-15
54031ORIG1900-01-01
53200ORIG1900-01-01
53199ORIG1900-01-01