docetaxel Injectable Solution

Brand(s)
Docefrez, Taxotere
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Actavis Inc. (2015-02-19)
Oldest Current Product
2010-08-02
License(s)
NDA, ANDA
RxNORM
INJECTABLE SOLUTION\DOCETAXEL
FDAOB
INJECTION\INJECTION\DOCETAXEL\rdfq
SPL Active
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOCETAXEL
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOCETAXEL ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\DOCETAXEL
INTRAVENOUS\INJECTION, SOLUTION\DOCETAXEL ANHYDROUS
INTRAVENOUS\SOLUTION\DOCETAXEL
SPL Moiety
INTRAVENOUS\INJECTION, SOLUTION, CONCENTRATE\DOCETAXEL ANHYDROUS
INTRAVENOUS\INJECTION, SOLUTION\DOCETAXEL ANHYDROUS
INTRAVENOUS\SOLUTION\DOCETAXEL ANHYDROUS

product(s) by strength(s)

docetaxel 10 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000699142NDAPfizer Labs2014-06-23DOCETAXEL ANHYDROUSINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA202356d2dc690b-4c69-428a-a67e-8ad007c39548
2000699144NDAPfizer Labs2014-06-23DOCETAXEL ANHYDROUSINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA202356d2dc690b-4c69-428a-a67e-8ad007c39548
3004090201NDAHospira, Inc.2011-03-08DOCETAXEL ANHYDROUSINTRAVENOUSINJECTION, SOLUTIONNDA022234a0ec4bcc-93ea-4c41-a4b6-95ec19491807

docetaxel 20 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000758003TaxotereNDASanofi-Aventis U.S. Llc2010-08-02DOCETAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA02044945e6dce4-92e2-4ad1-bf11-bbcefb753636
2009551021NDAWinthrop U.S.2010-10-21DOCETAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA020449dd0ca36d-1f54-4568-8d19-a7152addcd52
3167290231NDAAccord Healthcare Inc.2012-07-01DOCETAXELINTRAVENOUSINJECTION, SOLUTIONNDA201195f59f7811-70b7-4c44-99f7-4f4fdce3ed22
4250210222NDASagent Pharmaceuticals2013-07-01DOCETAXELINTRAVENOUSSOLUTIONNDA20355170aeb960-426c-4805-b956-476bebccd926
5459630765NDAActavis Inc.2014-09-01DOCETAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA2035512c806400-5fdc-4398-8475-37f700b3191f
6459630790NDAActavis Inc.2015-10-13DOCETAXELINTRAVENOUSINJECTION, SOLUTION, CONCENTRATENDA2035512c806400-5fdc-4398-8475-37f700b3191f
7637390971NDAMckesson Packaging Services A Business Unit Of Mckesson Corporation2011-06-08DOCETAXEL ANHYDROUSINTRAVENOUSINJECTION, SOLUTIONNDA201195c482c813-1eb7-40dd-907a-845a7df112bf

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1435980258ANDADr. Reddy'S Laboratories Inc2014-11-10DOCETAXELINTRAVENOUSINJECTION, SOLUTIONANDA204193a630937b-8369-74ad-b68a-f940eb16ff0f
2435980259ANDADr. Reddy'S Laboratories Inc2014-11-10DOCETAXELINTRAVENOUSINJECTION, SOLUTIONANDA204193a630937b-8369-74ad-b68a-f940eb16ff0f

docetaxel 25 mg/ml injectable solution

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)dose formapplicationspl
1473350285DocefrezNDASun Pharma Global Fze2011-05-03DOCETAXEL ANHYDROUSKITNDA022534b35e3633-8893-4b0b-af1e-92e342557199

docetaxel 40 mg/ml injectable solution

original product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1167290228NDAAccord Healthcare Inc.2011-06-30DOCETAXELINTRAVENOUSINJECTION, SOLUTIONNDA201195f59f7811-70b7-4c44-99f7-4f4fdce3ed22

application(s)

#idtitledeprecatedapplicantapprovedapproved drug
1ANDA203877DOCETAXELTEVA PHARMACEUTICALS USA2015-09-16ANDA203877_001, ANDA203877_002
2ANDA204193DOCETAXELDR REDDYS LABORATORIES LTD2014-11-05ANDA204193_001, ANDA204193_002
3NDA020449TAXOTERESANOFI AVENTIS US LLC1996-05-14NDA020449_001, NDA020449_003, NDA020449_004, NDA020449_005
4NDA022234DOCETAXELHOSPIRA INC2011-03-08NDA022234_001, NDA022234_002, NDA022234_003
5NDA022312DOCETAXELTrueAPOTEX INC2012-01-11NDA022312_001, NDA022312_002
6NDA022534DOCEFREZSUN PHARMA GLOBAL FZE2011-05-03NDA022534_001, NDA022534_002
7NDA201195DOCETAXELACCORD HEALTHCARE INC2011-06-08NDA201195_001, NDA201195_002, NDA201195_003, NDA201195_004, NDA201195_005
8NDA201525DOCETAXELSANDOZ2011-06-29NDA201525_001, NDA201525_002, NDA201525_003
9NDA202356DOCETAXELPFIZER LABS2014-03-13NDA202356_001, NDA202356_002, NDA202356_003, NDA202356_004
10NDA203551DOCETAXELACTAVIS INC2013-04-12NDA203551_001, NDA203551_002, NDA203551_003

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA203877_001RXDOCETAXEL (20MG/ML)INJECTIONFalseAP2015-09-16DOCETAXEL
2ANDA203877_002RXDOCETAXEL (80MG/4ML)INJECTIONFalseAP2015-09-16DOCETAXEL
3ANDA204193_001RXDOCETAXEL (20MG/ML)INJECTIONFalseAP2014-11-05DOCETAXEL
4ANDA204193_002RXDOCETAXEL (80MG/4ML)INJECTIONFalseAP2014-11-05DOCETAXEL
5NDA020449_001discontinuedDOCETAXEL (40MG/ML)INJECTIONFalse1996-05-14TAXOTERE
6NDA020449_003RXDOCETAXEL (20MG/ML)INJECTIONTrueAP2010-08-03TAXOTERE
7NDA020449_004RXDOCETAXEL (80MG/4ML)INJECTIONTrueAP2010-08-02TAXOTERE
8NDA020449_005RXDOCETAXEL (160MG/8ML)INJECTIONTrueAP2012-04-13TAXOTERE
9NDA022234_001RXDOCETAXEL (20MG/2ML)INJECTIONTrueAP2011-03-08DOCETAXEL
10NDA022234_002RXDOCETAXEL (80MG/8ML)INJECTIONTrueAP2011-03-08DOCETAXEL
11NDA022234_003RXDOCETAXEL (160MG/16ML)INJECTIONTrueAP2011-03-08DOCETAXEL
12NDA022312_001discontinuedDOCETAXEL (20MG/0.5ML)INJECTIONFalse2012-01-11DOCETAXEL
13NDA022312_002discontinuedDOCETAXEL (80MG/2ML)INJECTIONFalse2012-01-11DOCETAXEL
14NDA022534_001RXDOCETAXEL (20MG/VIAL)INJECTIONTrue2011-05-03DOCEFREZ
15NDA022534_002RXDOCETAXEL (80MG/VIAL)INJECTIONTrue2011-05-03DOCEFREZ
16NDA201195_001RXDOCETAXEL (20MG/0.5ML)INJECTIONFalse2011-06-08DOCETAXEL
17NDA201195_002RXDOCETAXEL (80MG/2ML)INJECTIONFalse2011-06-08DOCETAXEL
18NDA201195_003RXDOCETAXEL (20MG/ML)INJECTIONFalseAP2012-04-20DOCETAXEL
19NDA201195_004RXDOCETAXEL (80MG/4ML)INJECTIONFalseAP2012-04-20DOCETAXEL
20NDA201195_005RXDOCETAXEL (160MG/8ML)INJECTIONTrueAP2012-04-20DOCETAXEL
21NDA201525_001RXDOCETAXEL (20MG/2ML)INJECTIONFalseAP2011-06-29DOCETAXEL
22NDA201525_002RXDOCETAXEL (80MG/8ML)INJECTIONFalseAP2011-06-29DOCETAXEL
23NDA201525_003RXDOCETAXEL (160MG/16ML)INJECTIONFalseAP2011-06-29DOCETAXEL
24NDA202356_001RXDOCETAXEL (20MG/2ML)INJECTIONFalse2014-03-13DOCETAXEL
25NDA202356_002RXDOCETAXEL (80MG/8ML)INJECTIONFalse2014-03-13DOCETAXEL
26NDA202356_003RXDOCETAXEL (130MG/13ML)INJECTIONFalse2014-03-13DOCETAXEL
27NDA202356_004RXDOCETAXEL (200MG/20ML)INJECTIONFalse2014-03-13DOCETAXEL
28NDA203551_001RXDOCETAXEL (20MG/ML)INJECTIONFalseAP2013-04-12DOCETAXEL
29NDA203551_002RXDOCETAXEL (80MG/4ML)INJECTIONFalseAP2013-04-12DOCETAXEL
30NDA203551_003RXDOCETAXEL (140MG/7ML)INJECTIONFalse2013-04-12DOCETAXEL

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
12c806400-5fdc-4398-8475-37f700b3191f (view SPL)These highlights do not include all the information needed to use docetaxel injection concentrate safely and effectively. See full prescribing information for docetaxel injection concentrate. DOCETAXEL injection concentrate, for intravenous infusion (IV) Initial U.S. Approval: 1996prescriptionHuman PrescriptionActavis Inc.ANALYSIS, LABEL, MANUFACTURE, PACK2015-02-1925459630765, 459630790, 459630734, 459630781
245e6dce4-92e2-4ad1-bf11-bbcefb753636 (view SPL)These highlights do not include all the information needed to use TAXOTERE safely and effectively. See full prescribing information for TAXOTERE. TAXOTERE (docetaxel) Injection Concentrate, Intravenous Infusion (IV). Initial U.S. Approval: 1996prescriptionHuman PrescriptionSanofi-Aventis U.S. LlcANALYSIS, LABEL, MANUFACTURE, PACK2014-11-2013000758003, 000758004
370aeb960-426c-4805-b956-476bebccd926 (view SPL)These highlights do not include all the information needed to use docetaxel injection concentrate safely and effectively. See full prescribing information for docetaxel injection concentrate. Docetaxel Injection ConcentrateIntravenous Infusion (IV) Initial U.S. Approval: 1996prescriptionHuman PrescriptionSagent Pharmaceuticals2013-11-063250210222
4875b764f-10b2-448d-b50b-c9e8c1cfd69a (view SPL)These highlights do not include all the information needed to use Docetaxel Injection safely and effectively. See full prescribing information for Docetaxel Injection. DOCETAXEL INJECTION, Solution for Intravenous Infusion Initial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2014-10-151667580950
5a0ec4bcc-93ea-4c41-a4b6-95ec19491807 (view SPL)These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL INJECTION For intravenous infusion only. Initial U.S. Approval: 1996prescriptionHuman PrescriptionHospira, Inc.2014-07-2222004090201
6a630937b-8369-74ad-b68a-f940eb16ff0f (view SPL)ONE-VIAL FORMULATION These highlights do not include all the information needed to use docetaxel injection safety and effectively. See full prescribing information for docetaxel injection USP ONE- VIAL FORMULATION Docetaxel Injection, Intravenous Infusion (IV). Initial U.S. Approval: 1996prescriptionHuman PrescriptionDr. Reddy'S Laboratories Incanalysis, manufacture2014-12-157435980258, 435980259
7b35e3633-8893-4b0b-af1e-92e342557199 (view SPL)These highlights do not include all the information needed to use DOCEFREZ safely and effectively. See full prescribing information for DOCEFREZ. DOCEFREZ (docetaxel) for Injection, Intravenous InfusionInitial U.S. Approval: 1996prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2014-11-1310473350285
8c482c813-1eb7-40dd-907a-845a7df112bf (view SPL)These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION DOCETAXEL INJECTION, Intravenous Infusion. Initial U.S. Approval: 1996prescriptionHuman PrescriptionMckesson Packaging Services A Business Unit Of Mckesson CorporationANALYSIS, MANUFACTURE2015-03-125637390971, 637390932
9d2dc690b-4c69-428a-a67e-8ad007c39548 (view SPL)These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION. DOCETAXEL INJECTION, Intravenous Infusion.Initial U.S. Approval: 1996prescriptionHuman PrescriptionPfizer LabsANALYSIS, LABEL, MANUFACTURE, PACK2014-12-242000699142, 000699144, 000699141
10dd0ca36d-1f54-4568-8d19-a7152addcd52 (view SPL)These highlights do not include all the information needed to use docetaxel safely and effectively. See full prescribing information for docetaxel. Docetaxel Injection Concentrate, Intravenous Infusion (IV). Initial U.S. Approval: 1996prescriptionHuman PrescriptionWinthrop U.S.ANALYSIS, LABEL, MANUFACTURE, PACK2014-11-2111009551021, 009551020
11e03d1378-6889-43d5-a34c-f96132cffa88 (view SPL)These highlights do not include all the information needed to use Docetaxel Injection safely and effectively. See full prescribing information for Docetaxel Injection. DOCETAXEL INJECTION, Solution for Intravenous Infusion Initial U.S. Approval: 1996prescriptionHuman PrescriptionSandoz Inc2014-07-115667580050
12f59f7811-70b7-4c44-99f7-4f4fdce3ed22 (view SPL)These highlights do not include all the information needed to use DOCETAXEL INJECTION safely and effectively. See full prescribing information for DOCETAXEL INJECTION DOCETAXEL INJECTION, Intravenous Infusion. Initial U.S. Approval: 1996prescriptionHuman PrescriptionAccord Healthcare Inc.ANALYSIS, MANUFACTURE2014-09-2210167290228, 167290231, 167290120, 167290267

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII