FDA.reportPublic FDA data

Application 203551

Type
NDA
Sponsor
ACTAVIS LLC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DOCETAXELDOCETAXELINJECTABLE;INJECTION20MG/ML (20MG/ML)NoNo
002DOCETAXELDOCETAXELINJECTABLE;INJECTION80MG/4ML (20MG/ML)NoNo
003DOCETAXELDOCETAXELINJECTABLE;INJECTION140MG/7ML (20MG/ML)NoNo
004DOCETAXELDOCETAXELINJECTABLE;INJECTION160MG/8ML (20MG/ML)NoNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-734DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-765DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent
45963-790DocetaxelDocetaxelActavis Pharma, Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
79486SUPPL 2024-09-04
79494SUPPL 2024-08-29
64111SUPPL2020-07-28
64109SUPPL2020-07-28
59307SUPPL2019-07-10
59297SUPPL2019-07-10
53688SUPPL2018-04-16
53661SUPPL2018-04-12
32439SUPPL2014-09-23
19481SUPPL2014-09-19
32438SUPPL2013-11-07
19480SUPPL2013-11-04
24438ORIG2013-10-21
22926ORIG2013-10-21
40309ORIG2013-05-07
10230ORIG2013-04-16