FDA.reportPublic FDA data

Application 050794

Type
NDA
Sponsor
CELGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001VIDAZAAZACITIDINEPOWDER;INTRAVENOUS, SUBCUTANEOUS100MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-3253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
0781-3253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
0781-9253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
0781-9253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
0781-9253AzacitidineazacitidineSandoz IncNDA AUTHORIZED GENERICCurrent
59572-102VIDAZAazacitidineCelgene CorporationNDACurrent
59572-102VIDAZAazacitidineCelgene CorporationNDACurrent
59572-102VIDAZAazacitidineCelgene CorporationNDACurrent
59572-102VIDAZAazacitidineCelgene CorporationNDACurrent
59572-102VIDAZAazacitidineCelgene CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
78960SUPPL 2024-07-02
78956SUPPL 2024-07-02
72175SUPPL2022-09-28
71126SUPPL2022-05-23
71115SUPPL2022-05-20
62204SUPPL2020-03-19
62189SUPPL2020-03-19
55071SUPPL2018-08-02
54973SUPPL2018-07-25
45199SUPPL2016-08-23
45198SUPPL2016-08-23
39349SUPPL2015-12-24
30571SUPPL2015-12-18
8304SUPPL2014-01-14
18267SUPPL2014-01-13
39348SUPPL2012-12-21
30570SUPPL2012-01-27
39347SUPPL2012-01-25
39346SUPPL2011-08-24
18266SUPPL2011-08-24
30569SUPPL2011-08-22
8303SUPPL2011-08-22
39345SUPPL2008-08-26
8302SUPPL2008-08-22
30568SUPPL2008-02-25
39344SUPPL2007-02-02
30567SUPPL2005-07-08
22243ORIG2004-08-05
30566ORIG2004-05-26
18265ORIG2004-05-19