Application 205934

Type
NDA
Sponsor
TEIKOKU PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/ML (20MG/ML)NoNo
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/4ML (20MG/ML)NoNo
003DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/8ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
42367-121DocetaxeldocetaxelEagle Pharmaceuticals, InNDACurrent
42367-121DocetaxeldocetaxelEagle Pharmaceuticals, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74706SUPPL 2023-07-07
74696SUPPL 2023-07-06
68297SUPPL2021-08-05
68295SUPPL2021-08-05
61927SUPPL2020-02-20
61924SUPPL2020-02-20
43508ORIG2016-07-28
19700ORIG2015-12-28
10534ORIG2015-12-23