FDA.reportPublic FDA data

Application 021790

Type
NDA
Sponsor
OTSUKA PHARM CO LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DACOGENDECITABINEINJECTABLE;INTRAVENOUS50MG/VIALYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
59148-046DacogendecitabineOtsuka America Pharmaceutical, Inc.NDACurrent
59148-046DacogendecitabineOtsuka America PharmaceutNDACurrent
59148-046DacogendecitabineOtsuka America Pharmaceutical, Inc.NDACurrent
59148-046DacogendecitabineOtsuka America Pharmaceutical, Inc.NDACurrent
59148-046DacogendecitabineOtsuka America Pharmaceutical, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80626SUPPL 2024-12-18
80625SUPPL 2024-12-18
63758SUPPL2020-06-30
63754SUPPL2020-06-30
61972SUPPL2020-02-26
57085SUPPL2018-12-31
57009SUPPL2018-12-26
56841SUPPL2018-12-20
56713SUPPL2018-12-12
16377SUPPL2015-09-04
37652SUPPL2010-03-18
28608SUPPL2010-03-18
42313ORIG2006-06-16
28607ORIG2006-05-05
16376ORIG2006-05-04
52604ORIG1900-01-01
52603ORIG1900-01-01