temozolomide Oral Capsule

Brand(s)
Temodar
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Merck Sharp & Dohme Corp. (2015-05-12)
Oldest Current Product
1999-08-11
License(s)
NDA, NDA AUTHORIZED GENERIC, ANDA
RxNORM
ORAL CAPSULE\TEMOZOLOMIDE
FDAOB
ORAL\CAPSULE\TEMOZOLOMIDE
SPL Active
ORAL\CAPSULE\TEMOZOLOMIDE
SPL Moiety
ORAL\CAPSULE\TEMOZOLOMIDE

product(s) by strength(s)

temozolomide 100 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851366TemodarNDAMerck Sharp & Dohme Corp.1999-08-11TEMOZOLOMIDEORALCAPSULENDA021029046a9011-3911-4d3f-a15f-fbb56d5aad56

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937601ANDATeva Pharmaceuticals Usa Inc2013-08-12TEMOZOLOMIDEORALCAPSULEANDA078879baf02d0e-e7d2-4bb6-9f06-9e816cec3052
2007812693NDA AUTHORIZED GENERICSandoz Inc2013-08-12TEMOZOLOMIDEORALCAPSULENDA0210295d529b2d-d182-4d3d-a65d-613af39e254f
3473350892ANDASun Pharma Global Fze2014-02-13TEMOZOLOMIDEORALCAPSULEANDA201742c1e05c21-a411-4493-80de-ede373632475
4651620803ANDAAmneal Pharmaceuticals2015-04-03TEMOZOLOMIDEORALCAPSULEANDA2036916c8529ec-8936-4fec-a1a5-2b285c7e4859

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685350TemodarNDAPhysicians Total Care, Inc.2005-10-07TEMOZOLOMIDEORALCAPSULE000851366NDA021029819571ea-b808-4fd8-93c7-1ea2e33d71cf

temozolomide 140 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851425TemodarNDAMerck Sharp & Dohme Corp.1999-08-11TEMOZOLOMIDEORALCAPSULENDA021029046a9011-3911-4d3f-a15f-fbb56d5aad56

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937638ANDATeva Pharmaceuticals Usa Inc2013-08-12TEMOZOLOMIDEORALCAPSULEANDA078879baf02d0e-e7d2-4bb6-9f06-9e816cec3052
2007812694NDA AUTHORIZED GENERICSandoz Inc2013-08-12TEMOZOLOMIDEORALCAPSULENDA0210295d529b2d-d182-4d3d-a65d-613af39e254f
3473350929ANDASun Pharma Global Fze2014-02-13TEMOZOLOMIDEORALCAPSULEANDA201742c1e05c21-a411-4493-80de-ede373632475
4651620804ANDAAmneal Pharmaceuticals2015-04-03TEMOZOLOMIDEORALCAPSULEANDA2036916c8529ec-8936-4fec-a1a5-2b285c7e4859

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1691897638ANDAAvera Mckennan Hospital2015-06-11TEMOZOLOMIDEORALCAPSULE000937638ANDA07887945d9cc40-af5d-4bec-a310-9ae4d2a199b3

temozolomide 180 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851430TemodarNDAMerck Sharp & Dohme Corp.1999-08-11TEMOZOLOMIDEORALCAPSULENDA021029046a9011-3911-4d3f-a15f-fbb56d5aad56

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937639ANDATeva Pharmaceuticals Usa Inc2013-08-12TEMOZOLOMIDEORALCAPSULEANDA078879baf02d0e-e7d2-4bb6-9f06-9e816cec3052
2007812695NDA AUTHORIZED GENERICSandoz Inc2013-08-12TEMOZOLOMIDEORALCAPSULENDA0210295d529b2d-d182-4d3d-a65d-613af39e254f
3473350930ANDASun Pharma Global Fze2014-02-13TEMOZOLOMIDEORALCAPSULEANDA201742c1e05c21-a411-4493-80de-ede373632475
4651620805ANDAAmneal Pharmaceuticals2015-04-03TEMOZOLOMIDEORALCAPSULEANDA2036916c8529ec-8936-4fec-a1a5-2b285c7e4859

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685980TemodarNDAPhysicians Total Care, Inc.2009-01-26TEMOZOLOMIDEORALCAPSULE000851430NDA021029819571ea-b808-4fd8-93c7-1ea2e33d71cf

temozolomide 20 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851519TemodarNDAMerck Sharp & Dohme Corp.1999-08-11TEMOZOLOMIDEORALCAPSULENDA021029046a9011-3911-4d3f-a15f-fbb56d5aad56

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937600ANDATeva Pharmaceuticals Usa Inc2013-08-12TEMOZOLOMIDEORALCAPSULEANDA078879baf02d0e-e7d2-4bb6-9f06-9e816cec3052
2007812692NDA AUTHORIZED GENERICSandoz Inc2013-08-12TEMOZOLOMIDEORALCAPSULENDA0210295d529b2d-d182-4d3d-a65d-613af39e254f
3473350891ANDASun Pharma Global Fze2014-02-13TEMOZOLOMIDEORALCAPSULEANDA201742c1e05c21-a411-4493-80de-ede373632475
4651620802ANDAAmneal Pharmaceuticals2015-04-03TEMOZOLOMIDEORALCAPSULEANDA2036916c8529ec-8936-4fec-a1a5-2b285c7e4859

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548684142TemodarNDAPhysicians Total Care, Inc.2005-06-29TEMOZOLOMIDEORALCAPSULE000851519NDA021029819571ea-b808-4fd8-93c7-1ea2e33d71cf

temozolomide 250 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000851417TemodarNDAMerck Sharp & Dohme Corp.1999-08-11TEMOZOLOMIDEORALCAPSULENDA021029046a9011-3911-4d3f-a15f-fbb56d5aad56

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937602ANDATeva Pharmaceuticals Usa Inc2013-08-12TEMOZOLOMIDEORALCAPSULEANDA078879baf02d0e-e7d2-4bb6-9f06-9e816cec3052
2007812696NDA AUTHORIZED GENERICSandoz Inc2013-08-12TEMOZOLOMIDEORALCAPSULENDA0210295d529b2d-d182-4d3d-a65d-613af39e254f
3473350893ANDASun Pharma Global Fze2014-02-13TEMOZOLOMIDEORALCAPSULEANDA201742c1e05c21-a411-4493-80de-ede373632475
4651620806ANDAAmneal Pharmaceuticals2015-04-03TEMOZOLOMIDEORALCAPSULEANDA2036916c8529ec-8936-4fec-a1a5-2b285c7e4859

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685354TemodarNDAPhysicians Total Care, Inc.2006-04-13TEMOZOLOMIDEORALCAPSULE000851417NDA021029819571ea-b808-4fd8-93c7-1ea2e33d71cf

temozolomide 5 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000853004TemodarNDAMerck Sharp & Dohme Corp.1999-08-11TEMOZOLOMIDEORALCAPSULENDA021029046a9011-3911-4d3f-a15f-fbb56d5aad56

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1000937599ANDATeva Pharmaceuticals Usa Inc2013-08-12TEMOZOLOMIDEORALCAPSULEANDA078879baf02d0e-e7d2-4bb6-9f06-9e816cec3052
2007812691NDA AUTHORIZED GENERICSandoz Inc2013-08-12TEMOZOLOMIDEORALCAPSULENDA0210295d529b2d-d182-4d3d-a65d-613af39e254f
3473350890ANDASun Pharma Global Fze2014-02-13TEMOZOLOMIDEORALCAPSULEANDA201742c1e05c21-a411-4493-80de-ede373632475
4651620801ANDAAmneal Pharmaceuticals2015-04-03TEMOZOLOMIDEORALCAPSULEANDA2036916c8529ec-8936-4fec-a1a5-2b285c7e4859

relabeler product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1548685348TemodarNDAPhysicians Total Care, Inc.2005-10-20TEMOZOLOMIDEORALCAPSULE000853004NDA021029819571ea-b808-4fd8-93c7-1ea2e33d71cf

application(s)

#idtitleapplicantapprovedapproved drug
1ANDA078879TEMOZOLOMIDEBARR LABORATORIES INC2010-03-01ANDA078879_001, ANDA078879_002, ANDA078879_003, ANDA078879_004, ANDA078879_005, ANDA078879_006
2ANDA201742TEMOZOLOMIDESUN PHARMA GLOBAL FZE2014-02-12ANDA201742_001, ANDA201742_002, ANDA201742_003, ANDA201742_004, ANDA201742_005, ANDA201742_006
3ANDA203691TEMOZOLOMIDEAMNEAL PHARMACEUTICALS2015-05-08ANDA203691_001, ANDA203691_002, ANDA203691_003, ANDA203691_004, ANDA203691_005, ANDA203691_006
4NDA021029TEMODARMERCK SHARP AND DOHME CORP1999-08-11NDA021029_001, NDA021029_002, NDA021029_003, NDA021029_004, NDA021029_005, NDA021029_006

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldTEapprovedapplication
1ANDA078879_001RXTEMOZOLOMIDE (5MG)ORALCAPSULEFalseAB2010-03-01TEMOZOLOMIDE
2ANDA078879_002RXTEMOZOLOMIDE (20MG)ORALCAPSULEFalseAB2010-03-01TEMOZOLOMIDE
3ANDA078879_003RXTEMOZOLOMIDE (100MG)ORALCAPSULEFalseAB2010-03-01TEMOZOLOMIDE
4ANDA078879_004RXTEMOZOLOMIDE (250MG)ORALCAPSULEFalseAB2010-03-01TEMOZOLOMIDE
5ANDA078879_005RXTEMOZOLOMIDE (140MG)ORALCAPSULEFalseAB2010-03-01TEMOZOLOMIDE
6ANDA078879_006RXTEMOZOLOMIDE (180MG)ORALCAPSULEFalseAB2010-03-01TEMOZOLOMIDE
7ANDA201742_001RXTEMOZOLOMIDE (5MG)ORALCAPSULEFalseAB2014-02-12TEMOZOLOMIDE
8ANDA201742_002RXTEMOZOLOMIDE (20MG)ORALCAPSULEFalseAB2014-02-12TEMOZOLOMIDE
9ANDA201742_003RXTEMOZOLOMIDE (100MG)ORALCAPSULEFalseAB2014-02-12TEMOZOLOMIDE
10ANDA201742_004RXTEMOZOLOMIDE (140MG)ORALCAPSULEFalseAB2014-02-12TEMOZOLOMIDE
11ANDA201742_005RXTEMOZOLOMIDE (180MG)ORALCAPSULEFalseAB2014-02-12TEMOZOLOMIDE
12ANDA201742_006RXTEMOZOLOMIDE (250MG)ORALCAPSULEFalseAB2014-02-12TEMOZOLOMIDE
13ANDA203691_001RXTEMOZOLOMIDE (5MG)ORALCAPSULEFalseAB2015-05-08TEMOZOLOMIDE
14ANDA203691_002RXTEMOZOLOMIDE (20MG)ORALCAPSULEFalseAB2015-05-08TEMOZOLOMIDE
15ANDA203691_003RXTEMOZOLOMIDE (100MG)ORALCAPSULEFalseAB2015-05-08TEMOZOLOMIDE
16ANDA203691_004RXTEMOZOLOMIDE (140MG)ORALCAPSULEFalseAB2015-05-08TEMOZOLOMIDE
17ANDA203691_005RXTEMOZOLOMIDE (180MG)ORALCAPSULEFalseAB2015-05-08TEMOZOLOMIDE
18ANDA203691_006RXTEMOZOLOMIDE (250MG)ORALCAPSULEFalseAB2015-05-08TEMOZOLOMIDE
19NDA021029_001RXTEMOZOLOMIDE (5MG)ORALCAPSULEFalseAB1999-08-11TEMODAR
20NDA021029_002RXTEMOZOLOMIDE (20MG)ORALCAPSULEFalseAB1999-08-11TEMODAR
21NDA021029_003RXTEMOZOLOMIDE (100MG)ORALCAPSULEFalseAB1999-08-11TEMODAR
22NDA021029_004RXTEMOZOLOMIDE (250MG)ORALCAPSULETrueAB1999-08-11TEMODAR
23NDA021029_005RXTEMOZOLOMIDE (140MG)ORALCAPSULEFalseAB2006-10-19TEMODAR
24NDA021029_006RXTEMOZOLOMIDE (180MG)ORALCAPSULEFalseAB2006-10-19TEMODAR

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)in other drug docs
1046a9011-3911-4d3f-a15f-fbb56d5aad56 (view SPL)These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) CapsulesTEMODAR (temozolomide) for Injection administered via intravenous infusionInitial U.S. Approval: 1999prescriptionHuman PrescriptionMerck Sharp & Dohme Corp.API MANUFACTURE, MANUFACTURE, PACK2015-05-1222000851366, 000851417, 000851425, 000851430, 000851519, 000853004, 000851381temozolomide Injectable Solution
245d9cc40-af5d-4bec-a310-9ae4d2a199b3 (view SPL)These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for Temozolomide Capsules. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAvera Mckennan Hospitalrelabel, repack2015-11-191691897638
35d529b2d-d182-4d3d-a65d-613af39e254f (view SPL)These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for temozolomide. Temozolomide CapsulesTemozolomide for Injection marketed as TEMODAR Initial U.S. Approval: 1999prescriptionHuman PrescriptionSandoz IncAPI MANUFACTURE, MANUFACTURE, PACK2015-05-194007812691, 007812692, 007812693, 007812694, 007812695, 007812696
46c8529ec-8936-4fec-a1a5-2b285c7e4859 (view SPL)These highlights do not include all the information needed to use TEMOZOLOMIDE CAPSULES safely and effectively. See full prescribing information forTEMOZOLOMIDE CAPSULES. TEMOZOLOMIDE capsules for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionAmneal PharmaceuticalsANALYSIS, LABEL, MANUFACTURE, PACK2015-09-3010651620801, 651620802, 651620803, 651620804, 651620805, 651620806
5819571ea-b808-4fd8-93c7-1ea2e33d71cf (view SPL)These highlights do not include all the information needed to use TEMODAR safely and effectively. See full prescribing information for TEMODAR. TEMODAR (temozolomide) CapsulesTEMODAR (temozolomide) for Injection administered via intravenous infusionInitial U.S. Approval: 1999prescriptionHuman PrescriptionPhysicians Total Care, Inc.relabel, repack2011-02-091548684142, 548685348, 548685350, 548685354, 548685980
6baf02d0e-e7d2-4bb6-9f06-9e816cec3052 (view SPL)These highlights do not include all the information needed to use Temozolomide Capsules safely and effectively. See full prescribing information for Temozolomide Capsules. TEMOZOLOMIDE Capsules for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionTeva Pharmaceuticals Usa Inc2015-10-225000937599, 000937600, 000937601, 000937602, 000937638, 000937639
7c1e05c21-a411-4493-80de-ede373632475 (view SPL)These highlights do not include all the information needed to use TEMOZOLOMIDE safely and effectively. See full prescribing information for TEMOZOLOMIDE CAPSULES.TEMOZOLOMIDE capsules, for oral use Initial U.S. Approval: 1999prescriptionHuman PrescriptionSun Pharma Global FzeANALYSIS, MANUFACTURE2015-10-0315473350890, 473350891, 473350892, 473350893, 473350929, 473350930

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