FDA.report

Application 022311

Type
NDA
Sponsor
GENZYME

Related Records

Application Products

ProductDrugIngredientFormStrengthReference drugReference standard
001MOZOBILPLERIXAFORSOLUTION;SUBCUTANEOUS24MG/1.2ML (20MG/ML)YesYes

NDC Listings For This Application

NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent
0024-5862MozobilPLERIXAFORsanofi-aventis U.S. LLCNDACurrent

Documents

DocumentSubmission typeDate
75562SUPPL 2023-09-25
75535SUPPL 2023-09-22
64326SUPPL2020-08-20
64321SUPPL2020-08-20
58957SUPPL2019-06-04
58907SUPPL2019-05-31
50600SUPPL2017-12-04
50599SUPPL2017-12-04
38554SUPPL2015-08-06
7218SUPPL2015-08-06
17226SUPPL2014-12-10
29573SUPPL2014-12-05
38553SUPPL2013-06-11
7217SUPPL2013-06-06
7216SUPPL2010-06-16
38552SUPPL2010-06-15
42488ORIG2009-03-24
24279ORIG2009-03-24
17225ORIG2009-01-02
7215ORIG2008-12-19