FDA.reportPublic FDA data

Application 020912

Type
NDA
Sponsor
MEDICURE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AGGRASTATTIROFIBAN HYDROCHLORIDEINJECTABLE;INJECTIONEQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML)NoNo
002AGGRASTATTIROFIBAN HYDROCHLORIDESOLUTION;INJECTIONEQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
25208-001AGGRASTATTIROFIBANMedicure International IncNDACurrent
25208-001AGGRASTATTIROFIBANMedicure International IncNDACurrent
25208-001AGGRASTATTIROFIBANMedicure International IncNDACurrent
25208-001AGGRASTATTIROFIBANMedicure International IncNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
58793SUPPL2019-05-20
58768SUPPL2019-05-17
45214SUPPL2016-08-31
35634SUPPL2015-04-28
3734SUPPL2015-04-22
35633SUPPL2013-10-17
13730SUPPL2013-10-17
26182SUPPL2013-10-11
3733SUPPL2013-10-11
13729SUPPL2012-06-11
26181SUPPL2012-06-08
26180SUPPL2004-05-26
21274SUPPL2004-05-26
21273SUPPL2004-05-26
3732SUPPL2003-03-10
26179SUPPL2002-07-24
3731SUPPL2001-09-25
26178SUPPL2001-03-23
35632SUPPL1999-07-09
3730SUPPL1999-07-09
13728ORIG1998-05-14
3729ORIG1998-05-14