temozolomide Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
2589 85622-93-1

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • temomedac
  • SCH 52365
  • temozolomide
  • methazolastone
  • temodal
  • temozolamide
Temozolomide is not directly active but undergoes rapid nonenzymatic conversion at physiologic pH to the reactive compound 5-(3-methyltriazen1-yl)-imidazole-4-carboxamide (MTIC). The cytotoxicity of MTIC is thought to be primarily due to alkylation of DNA.
  • Molecular weight: 194.15
  • Formula: C6H6N6O2
  • CLOGP: -0.81
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 1
  • TPSA: 105.94
  • ALOGS: -1.58
  • ROTB: 1

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 5.60 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 25.46 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 96 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.50 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.60 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 1.50 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 11, 1999 FDA MERCK SHARP DOHME

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Thrombocytopenia 640.14 19.09 471 17974 126110 46541507
Disease progression 450.10 19.09 335 18110 90965 46576652
Pancytopenia 396.69 19.09 302 18143 84756 46582861
Bone marrow failure 291.69 19.09 168 18277 29501 46638116
Glioblastoma multiforme 281.01 19.09 66 18379 810 46666807
Malignant neoplasm progression 255.99 19.09 209 18236 64717 46602900
Tumour pseudoprogression 248.21 19.09 45 18400 124 46667493
Glioblastoma 207.15 19.09 51 18394 773 46666844
Platelet count decreased 192.96 19.09 217 18228 99807 46567810
Seizure 164.59 19.09 222 18223 122832 46544785
Neoplasm progression 151.76 19.09 107 18338 26576 46641041
Lymphopenia 151.26 19.09 87 18358 15206 46652411
Product use in unapproved indication 136.36 19.09 173 18272 90100 46577517
Myelosuppression 134.08 19.09 64 18381 7639 46659978
Hypermutation 128.64 19.09 20 18425 10 46667607
Brain oedema 120.77 19.09 70 18375 12408 46655209
Haematotoxicity 118.84 19.09 57 18388 6876 46660741
Anaplastic astrocytoma 116.60 19.09 21 18424 55 46667562
Neutropenia 114.80 19.09 204 18241 143000 46524617
Febrile neutropenia 110.42 19.09 160 18285 94467 46573150
Off label use 105.40 19.09 359 18086 379482 46288135
Aplastic anaemia 105.26 19.09 53 18392 7100 46660517
Leukopenia 103.19 19.09 131 18314 68212 46599405
Metastases to liver 87.63 19.09 68 18377 19517 46648100
Death 85.91 19.09 309 18136 335239 46332378
Herpes simplex encephalitis 72.25 19.09 18 18427 287 46667330
Malignant glioma 71.88 19.09 12 18433 16 46667601
Radiation necrosis 65.99 19.09 17 18428 312 46667305
Brain neoplasm malignant 65.79 19.09 21 18424 846 46666771
Hemiparesis 65.41 19.09 58 18387 20011 46647606
Disease recurrence 61.43 19.09 54 18391 18417 46649200
Febrile bone marrow aplasia 57.27 19.09 35 18410 6827 46660790
Pneumocystis jirovecii pneumonia 55.62 19.09 47 18398 15201 46652416
Lymphocyte count decreased 55.25 19.09 59 18386 25530 46642087
Petechiae 54.52 19.09 43 18402 12627 46654990
White blood cell count decreased 54.37 19.09 130 18315 112101 46555516
Metastases to central nervous system 52.46 19.09 40 18405 11181 46656436
Angina bullosa haemorrhagica 52.11 19.09 12 18433 134 46667483
Hydrocephalus 51.58 19.09 29 18416 4848 46662769
Neoplasm recurrence 51.55 19.09 23 18422 2350 46665267
Brain neoplasm 46.68 19.09 25 18420 3799 46663818
Brain stem glioma 46.54 19.09 10 18435 79 46667538
Hospice care 44.17 19.09 27 18418 5268 46662349
Joint swelling 43.04 19.09 7 18438 166066 46501551
Arthralgia 42.46 19.09 49 18396 364554 46303063
Muscle swelling 41.08 19.09 12 18433 357 46667260
Pulmonary embolism 39.48 19.09 113 18332 108472 46559145
Crystal nephropathy 38.97 19.09 14 18431 811 46666806
Facial asymmetry 38.16 19.09 13 18432 643 46666974
Early satiety 35.91 19.09 13 18432 770 46666847
Intracranial tumour haemorrhage 35.75 19.09 9 18436 150 46667467
Desmoplastic small round cell tumour 35.69 19.09 9 18436 151 46667466
Metastatic malignant melanoma 35.65 19.09 15 18430 1329 46666288
Blood disorder 35.34 19.09 24 18421 5603 46662014
Pain 35.26 19.09 86 18359 476862 46190755
Neutrophil count decreased 34.87 19.09 62 18383 43364 46624253
Agranulocytosis 34.19 19.09 43 18402 22142 46645475
Vulval disorder 34.02 19.09 12 18433 659 46666958
Enterocutaneous fistula 33.76 19.09 14 18431 1196 46666421
Vasogenic cerebral oedema 33.68 19.09 11 18434 477 46667140
Sialoadenitis 33.00 19.09 14 18431 1266 46666351
Central nervous system necrosis 32.32 19.09 8 18437 124 46667493
Nausea 32.25 19.09 413 18032 687041 45980576
Anxiety 31.93 19.09 16 18429 181941 46485676
Aplasia 31.80 19.09 19 18426 3557 46664060
Pneumonia fungal 31.63 19.09 20 18425 4140 46663477
Optic neuropathy 31.48 19.09 15 18430 1781 46665836
Metastases to peritoneum 31.45 19.09 17 18428 2631 46664986
Ganglioneuroma 31.30 19.09 8 18437 142 46667475
Sepsis 31.07 19.09 121 18324 135893 46531724
Vomiting 30.31 19.09 292 18153 452502 46215115
Neutrophil count abnormal 29.86 19.09 16 18429 2434 46665183
Dyspnoea 28.71 19.09 106 18339 515442 46152175
Tumour haemorrhage 28.47 19.09 13 18432 1402 46666215
Drug hypersensitivity 28.09 19.09 33 18412 243792 46423825
Musculoskeletal stiffness 28.08 19.09 3 18442 97990 46569627
DNULL mismatch repair protein gene mutation 27.35 19.09 4 18441 0 46667617
Oligoastrocytoma 27.35 19.09 4 18441 0 46667617
Coagulation time prolonged 26.21 19.09 12 18433 1302 46666315
Cerebral haemorrhage 26.05 19.09 43 18402 28328 46639289
Recurrent cancer 25.77 19.09 13 18432 1746 46665871
Metastases to lymph nodes 25.34 19.09 21 18424 6610 46661007
Drug clearance decreased 25.14 19.09 11 18434 1073 46666544
Sinusitis 24.97 19.09 10 18435 129758 46537859
Peripheral swelling 24.72 19.09 16 18429 158055 46509562
Depression 24.27 19.09 19 18426 170085 46497532
Bronchitis 24.25 19.09 6 18439 105973 46561644
Therapy change 23.47 19.09 18 18427 5072 46662545
White blood cell count abnormal 23.34 19.09 18 18427 5114 46662503
Liver abscess 23.31 19.09 14 18431 2645 46664972
Arthropathy 23.25 19.09 3 18442 84697 46582920
Pain in extremity 22.95 19.09 42 18403 258638 46408979
Hyperhidrosis 22.60 19.09 4 18441 89304 46578313
Ecchymosis 22.14 19.09 24 18421 10552 46657065
Tumour necrosis 21.74 19.09 9 18436 766 46666851
Infrequent bowel movements 21.73 19.09 10 18435 1098 46666519
Gastroenteropancreatic neuroendocrine tumour disease 21.70 19.09 5 18440 56 46667561
Deep vein thrombosis 21.59 19.09 75 18370 79698 46587919
Malaise 21.21 19.09 64 18381 331168 46336449
General physical health deterioration 20.98 19.09 96 18349 115673 46551944
Infusion related reaction 20.82 19.09 7 18438 101201 46566416
Brain tumour operation 20.72 19.09 4 18441 17 46667600
Radiation interaction 20.51 19.09 3 18442 0 46667617
Gliosarcoma 20.51 19.09 3 18442 0 46667617
Mental status changes 20.47 19.09 46 18399 38042 46629575
Haemoglobin 20.43 19.09 6 18439 182 46667435
Dehydration 20.38 19.09 120 18325 159420 46508197
Oesophagitis 20.30 19.09 26 18419 13625 46653992
Lethargy 20.29 19.09 55 18390 51116 46616501
Myalgia 19.88 19.09 12 18433 123076 46544541
Gastrooesophageal reflux disease 19.55 19.09 3 18442 74341 46593276
Cardiac failure congestive 19.48 19.09 6 18439 91744 46575873
Ascites 19.46 19.09 44 18401 36540 46631077
Needle issue 19.36 19.09 17 18428 5787 46661830
IIIrd nerve paralysis 19.27 19.09 8 18437 685 46666932
Mucocutaneous rash 19.17 19.09 4 18441 27 46667590

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Disease progression 584.61 16.63 446 18285 79428 29854319
Glioblastoma 272.18 16.63 75 18656 1110 29932637
Glioblastoma multiforme 271.24 16.63 70 18661 793 29932954
Malignant neoplasm progression 222.18 16.63 249 18482 72038 29861709
Tumour pseudoprogression 217.27 16.63 49 18682 295 29933452
Neoplasm progression 216.89 16.63 137 18594 17886 29915861
Lymphopenia 191.52 16.63 113 18618 13050 29920697
Thrombocytopenia 180.84 16.63 314 18417 136730 29797017
Seizure 162.81 16.63 250 18481 98225 29835522
Product use in unapproved indication 143.25 16.63 202 18529 73491 29860256
Brain oedema 131.27 16.63 87 18644 12311 29921436
Nausea 120.93 16.63 433 18298 296524 29637223
Myelosuppression 101.62 16.63 61 18670 7261 29926486
Pancreatic neuroendocrine tumour metastatic 99.74 16.63 23 18708 155 29933592
Death 97.13 16.63 460 18271 356823 29576924
Lymphocyte count decreased 96.04 16.63 86 18645 18969 29914778
Anaplastic astrocytoma 90.75 16.63 21 18710 144 29933603
Off label use 86.72 16.63 346 18385 248944 29684803
Pulmonary embolism 80.18 16.63 161 18570 77974 29855773
Vomiting 78.72 16.63 308 18423 219510 29714237
Brain neoplasm malignant 78.20 16.63 24 18707 527 29933220
Brain neoplasm 74.91 16.63 36 18695 2741 29931006
Hypermutation 69.83 16.63 12 18719 9 29933738
Platelet count decreased 66.31 16.63 180 18551 105949 29827798
Neoplasm recurrence 65.35 16.63 29 18702 1838 29931909
Hemiparesis 65.24 16.63 62 18669 14740 29919007
Brain operation 64.46 16.63 18 18713 280 29933467
Intracranial tumour haemorrhage 62.97 16.63 18 18713 306 29933441
Bone marrow failure 62.78 16.63 85 18646 29700 29904047
Aphasia 59.60 16.63 67 18664 19372 29914375
Malignant glioma 59.20 16.63 12 18719 39 29933708
Disease recurrence 58.05 16.63 57 18674 14104 29919643
Constipation 56.58 16.63 177 18554 112729 29821018
Pancytopenia 54.85 16.63 146 18585 84906 29848841
Hydrocephalus 52.90 16.63 33 18698 4204 29929543
Astrocytoma 48.86 16.63 13 18718 167 29933580
Radiation necrosis 47.84 16.63 11 18720 73 29933674
Deep vein thrombosis 47.53 16.63 112 18619 60389 29873358
Diaphragmatic spasm 46.85 16.63 11 18720 81 29933666
Faecal volume decreased 46.38 16.63 11 18720 85 29933662
Pneumocystis jirovecii pneumonia 45.77 16.63 55 18676 17065 29916682
Hospice care 44.12 16.63 30 18701 4422 29929325
Haematotoxicity 41.71 16.63 33 18698 6137 29927610
Myocardial infarction 38.83 16.63 15 18716 125610 29808137
Oligodendroglioma 38.37 16.63 8 18723 31 29933716
Aplastic anaemia 38.17 16.63 30 18701 5526 29928221
Metastases to liver 37.97 16.63 42 18689 11923 29921824
Recurrent cancer 37.13 16.63 17 18714 1159 29932588
Metastases to lung 34.65 16.63 33 18698 7862 29925885
Metastases to meninges 33.73 16.63 16 18715 1183 29932564
Glioma 33.31 16.63 11 18720 308 29933439
Arthralgia 33.31 16.63 22 18709 135769 29797978
Swelling of eyelid 32.59 16.63 11 18720 330 29933417
Tumour haemorrhage 32.35 16.63 20 18711 2508 29931239
Cardiac failure congestive 31.70 16.63 7 18724 84400 29849347
Intussusception 30.95 16.63 12 18719 539 29933208
Diabetes insipidus 29.38 16.63 18 18713 2221 29931526
Febrile bone marrow aplasia 28.45 16.63 30 18701 8067 29925680
Hepatic lesion 28.41 16.63 20 18711 3116 29930631
Medulloblastoma 28.37 16.63 7 18724 65 29933682
Neuroblastoma 28.22 16.63 9 18722 225 29933522
Metastatic malignant melanoma 28.08 16.63 17 18714 2053 29931694
Dyspnoea 27.75 16.63 111 18620 333184 29600563
Confusional state 27.61 16.63 161 18570 134673 29799074
Brain stem glioma 27.52 16.63 5 18726 7 29933740
Epilepsy 27.47 16.63 47 18684 20122 29913625
Alanine aminotransferase increased 27.18 16.63 105 18626 74171 29859576
Acute kidney injury 26.91 16.63 85 18646 273757 29659990
Intracranial pressure increased 26.50 16.63 20 18711 3470 29930277
Hippocampal sclerosis 26.23 16.63 7 18724 91 29933656
Mixed liver injury 26.09 16.63 16 18715 1977 29931770
Hyperglycaemia 25.30 16.63 63 18668 35137 29898610
Skin warm 24.63 16.63 15 18716 1831 29931916
Hypotension 24.40 16.63 56 18675 200509 29733238
Metastases to central nervous system 23.86 16.63 26 18705 7258 29926489
Metastasis 23.07 16.63 18 18713 3280 29930467
Therapy cessation 22.93 16.63 37 18694 15100 29918647
Gait disturbance 22.85 16.63 100 18631 74677 29859070
Brain tumour operation 22.74 16.63 4 18727 4 29933743
Rhabdomyolysis 22.44 16.63 6 18725 63574 29870173
Herpes simplex encephalitis 22.21 16.63 8 18723 292 29933455
Hemiplegia 22.21 16.63 24 18707 6637 29927110
Paraparesis 22.20 16.63 14 18717 1817 29931930
Porokeratosis 22.01 16.63 6 18725 85 29933662
White blood cell count decreased 21.06 16.63 106 18625 83841 29849906
Drug interaction 20.97 16.63 60 18671 199508 29734239
Petechiae 20.67 16.63 27 18704 9104 29924643
Hyperkalaemia 20.18 16.63 8 18723 66002 29867745
Central nervous system necrosis 20.17 16.63 6 18725 118 29933629
Rosacea 20.12 16.63 11 18720 1096 29932651
Unmasking of previously unidentified disease 20.00 16.63 9 18722 589 29933158
Nephrogenic diabetes insipidus 19.35 16.63 11 18720 1182 29932565
Postoperative wound complication 19.33 16.63 9 18722 638 29933109
Astrocytoma malignant 19.13 16.63 3 18728 0 29933747
Malignant oligodendroglioma 19.13 16.63 3 18728 0 29933747
Hereditary motor and sensory neuropathy 19.08 16.63 4 18727 16 29933731
Alopecia 18.87 16.63 39 18692 19236 29914511
Ataxia 18.71 16.63 29 18702 11433 29922314
Herpes simplex pneumonia 18.70 16.63 4 18727 18 29933729
Acute myocardial infarction 18.68 16.63 5 18726 52934 29880813
Generalised tonic-clonic seizure 18.48 16.63 39 18692 19512 29914235
Bradycardia 18.36 16.63 9 18722 65517 29868230
Ependymoma 18.14 16.63 5 18726 74 29933673
Pneumocystis jirovecii infection 18.12 16.63 11 18720 1334 29932413
Toxicity to various agents 18.08 16.63 54 18677 177129 29756618
Cardiac arrest 17.88 16.63 19 18712 92831 29840916
Craniotomy 17.83 16.63 5 18726 79 29933668
Fatigue 17.73 16.63 290 18441 320383 29613364
Joint swelling 17.40 16.63 4 18727 46942 29886805
Psoriasis 17.05 16.63 3 18728 42503 29891244
Neurological decompensation 16.92 16.63 13 18718 2315 29931432
Metastases to skin 16.92 16.63 7 18724 373 29933374
Atrial fibrillation 16.81 16.63 26 18705 108098 29825649

Pharmacologic Action:

SourceCodeDescription
ATC L01AX03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Other alkylating agents
FDA MoA N0000000236 Alkylating Activity
FDA EPC N0000175558 Alkylating Drug
MeSH PA D000477 Alkylating Agents
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D009676 Noxae
CHEBI has role CHEBI:35610 cytostatic
CHEBI has role CHEBI:50266 prodrugs

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Astrocytoma, anaplastic indication 55353007 DOID:3078
Glioblastoma multiforme of brain indication 276828006 DOID:3073
Ewing's sarcoma off-label use 76909002 DOID:3369
Metastatic malignant melanoma off-label use 443493003
Pancreatic Neuroendocrine Tumor off-label use
Lymphocytopenia contraindication 48813009 DOID:614
Acute nephropathy contraindication 58574008
Hepatic failure contraindication 59927004
Myelodysplastic syndrome contraindication 109995007
Pancytopenia contraindication 127034005 DOID:12450
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Aplastic anemia contraindication 306058006 DOID:12449
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001
Pneumocystosis jiroveci pneumonia contraindication 415125002 DOID:11339

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.94 acidic
pKa2 1.16 Basic
pKa3 0.53 Basic

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA DNA OTHER DRUG LABEL DRUG LABEL

External reference:

IDSource
4021173 VUID
N0000148622 NUI
D06067 KEGG_DRUG
4021173 VANDF
C0076080 UMLSCUI
CHEBI:72564 CHEBI
CHEMBL810 ChEMBL_ID
D000077204 MESH_DESCRIPTOR_UI
DB00853 DRUGBANK_ID
6027 INN_ID
YF1K15M17Y UNII
5394 PUBCHEM_CID
7301 IUPHAR_LIGAND_ID
37776 RXNORM
172754 MMSL
8290 MMSL
d04451 MMSL
007794 NDDF
116099008 SNOMEDCT_US
387009002 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1366 CAPSULE 100 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1381 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1417 CAPSULE 250 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1425 CAPSULE 140 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1430 CAPSULE 180 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1519 CAPSULE 20 mg ORAL NDA 33 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-3004 CAPSULE 5 mg ORAL NDA 33 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1777 CAPSULE 5 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1778 CAPSULE 20 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1779 CAPSULE 100 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1780 CAPSULE 140 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1781 CAPSULE 180 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1782 CAPSULE 250 mg ORAL ANDA 28 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2691 CAPSULE 5 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2692 CAPSULE 20 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2693 CAPSULE 100 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2694 CAPSULE 140 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2695 CAPSULE 180 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2696 CAPSULE 250 mg ORAL NDA AUTHORIZED GENERIC 31 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-048 CAPSULE 5 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-049 CAPSULE 20 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-050 CAPSULE 100 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-051 CAPSULE 250 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-129 CAPSULE 140 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-130 CAPSULE 180 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 43975-252 CAPSULE 5 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 43975-253 CAPSULE 20 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 43975-254 CAPSULE 100 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 43975-255 CAPSULE 140 mg ORAL ANDA 30 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 43975-256 CAPSULE 180 mg ORAL ANDA 30 sections