FDA.reportPublic FDA data

Application 022393

Type
NDA
Sponsor
CELGENE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001ISTODAXROMIDEPSINPOWDER;INTRAVENOUS10MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0069-0983RomidepsinromidepsinPFIZER LABORATORIES DIV PFIZER INCNDA AUTHORIZED GENERICCurrent
0069-0983RomidepsinromidepsinPFIZER LABORATORIES DIV PFIZER INCNDA AUTHORIZED GENERICCurrent
0703-3125RomidepsinromidepsinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-3125RomidepsinromidepsinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-3125RomidepsinromidepsinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-3125RomidepsinromidepsinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
0703-3125RomidepsinromidepsinTeva Parenteral Medicines, Inc.NDA AUTHORIZED GENERICCurrent
59572-984ISTODAXromidepsinCelgene CorporationNDACurrent
59572-984ISTODAXromidepsinCelgene CorporationNDACurrent
59572-984ISTODAXromidepsinCelgene CorporationNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
68273SUPPL2021-08-03
68237SUPPL2021-08-02
67615SUPPL2021-05-27
66867SUPPL2021-03-25
59287SUPPL2019-07-09
56773SUPPL2018-12-18
7318SUPPL2016-08-01
38651SUPPL2016-07-28
29673SUPPL2014-10-21
17308SUPPL2014-10-16
17307SUPPL2013-06-18
7317SUPPL2013-06-14
7316SUPPL2011-10-03
38650SUPPL2011-09-30
29672SUPPL2011-06-27
17306SUPPL2011-06-16
38649SUPPL2011-04-15
29671SUPPL2011-04-15
44745ORIG2010-01-04
42505ORIG2010-01-04
7315ORIG2009-11-13
38648ORIG2009-11-06