FDA.reportPublic FDA data

Application 020449

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAXOTEREDOCETAXELINJECTABLE;INJECTION40MG/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003TAXOTEREDOCETAXELINJECTABLE;INJECTION20MG/ML (20MG/ML)YesYes
004TAXOTEREDOCETAXELINJECTABLE;INJECTION80MG/4ML (20MG/ML)YesYes
005TAXOTEREDOCETAXELINJECTABLE;INJECTION160MG/8ML (20MG/ML)YesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0075-8003TAXOTEREDocetaxelsanofi-aventis U.S. LLCNDACurrent
0075-8003TAXOTEREDocetaxelSanofi-Aventis U.S. LLCNDACurrent
0075-8003TAXOTEREDocetaxelSanofi-Aventis U.S. LLCNDACurrent
0075-8004TAXOTEREDocetaxelSanofi-Aventis U.S. LLCNDACurrent
0075-8004TAXOTEREDocetaxelsanofi-aventis U.S. LLCNDACurrent
0075-8004TAXOTEREDocetaxelSanofi-Aventis U.S. LLCNDACurrent
0075-8004TAXOTEREDocetaxelSanofi-Aventis U.S. LLCNDACurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1020DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1021DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent
0955-1022DocetaxelDocetaxelWinthrop U.S.NDA AUTHORIZED GENERICCurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80158SUPPL 2024-11-05
73282SUPPL2023-01-25
73248SUPPL2023-01-19
71299SUPPL2022-06-14
71287SUPPL2022-06-13
64009SUPPL2020-07-22
64008SUPPL2020-07-22
63144SUPPL2020-05-19
63088SUPPL2020-05-19
61364SUPPL2019-12-20
61330SUPPL2019-12-18
58991SUPPL2019-06-07
58990SUPPL2019-06-07
58985SUPPL2019-06-07
58984SUPPL2019-06-07
58918SUPPL2019-06-03
55933SUPPL2018-10-15
55855SUPPL2018-10-09
20664SUPPL2016-07-27
24984SUPPL2015-12-15
12596SUPPL2015-12-15
12591SUPPL2015-04-14
12595SUPPL2014-11-20
2552SUPPL2014-11-17
41373SUPPL2014-07-07
20663SUPPL2014-07-07
12594SUPPL2013-12-17
2551SUPPL2013-12-16
12593SUPPL2013-07-08
24983SUPPL2013-06-27
41374SUPPL2012-10-15
34665SUPPL2011-12-20
2550SUPPL2011-12-20
41372SUPPL2011-09-22
12592SUPPL2011-09-16
2549SUPPL2011-09-12
24980SUPPL2010-06-08
2548SUPPL2010-05-18
34664SUPPL2010-05-17
12590SUPPL2010-05-03
12588SUPPL2010-05-03
24982SUPPL2010-04-23
2547SUPPL2010-04-23
24981SUPPL2007-10-04
12589SUPPL2007-10-04
51516SUPPL2007-06-11
2546SUPPL2006-10-23
12587SUPPL2006-10-18
44604SUPPL2006-06-08
34663SUPPL2006-06-08
24979SUPPL2006-06-08
12586SUPPL2006-04-05
2545SUPPL2006-04-05
2544SUPPL2005-11-18
34662SUPPL2005-08-15
24978SUPPL2005-08-15
41371SUPPL2005-04-27
20662SUPPL2005-04-15
2543SUPPL2005-01-11
2542SUPPL2004-08-25
34661SUPPL2004-08-19
34659SUPPL2004-06-18
12584SUPPL2004-06-18
24977SUPPL2004-05-26
12585SUPPL2004-05-19
41370SUPPL2003-07-08
24974SUPPL2003-05-29
34658SUPPL2003-04-28
34660SUPPL2003-01-30
24976SUPPL2003-01-30
24975SUPPL2003-01-30
2540SUPPL2003-01-30
12583SUPPL2002-11-27
2541SUPPL2002-11-27
20661SUPPL2001-07-05
41369SUPPL2000-07-11
34657SUPPL1999-12-23
24973SUPPL1999-12-23
24972SUPPL1998-06-22
2539SUPPL1998-06-22
57458ORIG1996-05-14
58106ORIG1900-01-01
54106ORIG1900-01-01
54105ORIG1900-01-01
54104ORIG1900-01-01