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 1325.13 39.93 367 3112 18764 2335842
Pancytopenia 1006.85 39.93 266 3213 11186 2343420
Disease progression 792.26 39.93 241 3238 16854 2337752
Bone marrow failure 584.15 39.93 150 3329 5536 2349070
Malignant neoplasm progression 556.14 39.93 170 3309 11958 2342648
Platelet count decreased 495.73 39.93 166 3313 15647 2338959
Neutropenia 430.80 39.93 162 3317 21386 2333220
Febrile neutropenia 391.77 39.93 127 3352 10755 2343851
Lymphopenia 373.96 39.93 89 3390 2365 2352241
Glioblastoma multiforme 369.57 39.93 59 3420 146 2354460
Nausea 323.45 39.93 227 3252 111962 2242644
Seizure 311.34 39.93 133 3346 24333 2330273
Vomiting 280.95 39.93 176 3303 71426 2283180
White blood cell count decreased 278.67 39.93 113 3366 18095 2336511
Leukopenia 271.64 39.93 95 3384 10101 2344505
Sepsis 249.83 39.93 105 3374 18383 2336223
Pyrexia 243.47 39.93 145 3334 53563 2301043
Pulmonary embolism 228.65 39.93 98 3381 17985 2336621
Asthenia 223.80 39.93 131 3348 46795 2307811
Aplastic anaemia 219.61 39.93 48 3431 856 2353750
Off label use 215.66 39.93 151 3328 73447 2281159
Neoplasm progression 215.49 39.93 66 3413 4602 2350004
Lymphocyte count decreased 196.24 39.93 57 3422 3306 2351300
Product use in unapproved indication 193.62 39.93 76 3403 11124 2343482
Death 192.92 39.93 147 3332 81321 2273285
Dehydration 187.53 39.93 91 3388 22204 2332402
Pneumonia 182.14 39.93 117 3362 49179 2305427
Fatigue 181.06 39.93 144 3335 84729 2269877
Alanine aminotransferase increased 177.05 39.93 76 3403 13956 2340650
Pneumocystis jirovecii pneumonia 175.63 39.93 48 3431 2225 2352381
Anaemia 167.83 39.93 98 3381 34694 2319912
Drug ineffective 166.37 39.93 148 3331 101476 2253130
Deep vein thrombosis 166.28 39.93 71 3408 12861 2341745
Glioblastoma 163.82 39.93 30 3449 202 2354404
Brain oedema 161.04 39.93 45 3434 2265 2352341
General physical health deterioration 153.77 39.93 69 3410 14070 2340536
Disease recurrence 151.60 39.93 47 3432 3404 2351202
Hemiparesis 147.40 39.93 46 3433 3404 2351202
Haemoglobin decreased 146.24 39.93 72 3407 18079 2336527
Febrile bone marrow aplasia 140.36 39.93 33 3446 824 2353782
Petechiae 138.21 39.93 39 3440 2033 2352573
Urinary tract infection 135.50 39.93 81 3398 29861 2324745
Neutrophil count decreased 125.57 39.93 48 3431 6519 2348087
Metastases to liver 124.73 39.93 39 3440 2902 2351704
Decreased appetite 122.55 39.93 75 3404 28816 2325790
Anaplastic astrocytoma 117.78 39.93 18 3461 29 2354577
Rash 115.85 39.93 96 3383 59462 2295144
Agranulocytosis 114.24 39.93 38 3441 3444 2351162
Bone marrow toxicity 113.87 39.93 24 3455 356 2354250
Aspartate aminotransferase increased 113.48 39.93 54 3425 12558 2342048
Fall 106.57 39.93 83 3396 47016 2307590
Confusional state 105.24 39.93 64 3415 24280 2330326
Herpes simplex encephalitis 103.85 39.93 18 3461 84 2354522
Haematotoxicity 101.16 39.93 27 3452 1140 2353466
Hypotension 100.13 39.93 69 3410 32367 2322239
Headache 98.67 39.93 100 3379 80079 2274527
Hydrocephalus 98.11 39.93 25 3454 878 2353728
Metastases to central nervous system 97.44 39.93 30 3449 2118 2352488
Aplasia 97.03 39.93 22 3457 465 2354141
Mental status changes 96.73 39.93 38 3441 5544 2349062
Lethargy 96.06 39.93 43 3436 8687 2345919
Diarrhoea 89.86 39.93 97 3382 83467 2271139
Oesophagitis 82.52 39.93 26 3453 1980 2352626
Radiation necrosis 80.30 39.93 14 3465 68 2354538
Hyperglycaemia 80.24 39.93 32 3447 4853 2349753
Hepatic function abnormal 80.00 39.93 34 3445 6058 2348548
Septic shock 78.40 39.93 35 3444 7019 2347587
Neoplasm recurrence 78.23 39.93 18 3461 407 2354199
Respiratory failure 78.19 39.93 43 3436 13485 2341121
Lung infiltration 75.40 39.93 25 3454 2239 2352367
Ascites 72.58 39.93 31 3448 5589 2349017
Myelodysplastic syndrome 72.39 39.93 25 3454 2535 2352071
Magnetic resonance imaging brain abnormal 72.36 39.93 17 3462 422 2354184
Hepatotoxicity 72.11 39.93 27 3452 3454 2351152
Metastases to peritoneum 71.65 39.93 17 3462 441 2354165
Cholestasis 70.36 39.93 27 3452 3694 2350912
Cerebral haemorrhage 69.89 39.93 30 3449 5474 2349132
Brain stem glioma 69.71 39.93 10 3469 7 2354599
Metastases to lymph nodes 67.84 39.93 19 3460 961 2353645
Ecchymosis 67.11 39.93 21 3458 1562 2353044
Constipation 66.62 39.93 46 3433 21583 2333023
Gamma-glutamyltransferase increased 66.31 39.93 29 3450 5533 2349073
Hepatitis 65.83 39.93 30 3449 6307 2348299
Hypokalaemia 64.69 39.93 35 3444 10619 2343987
White blood cell count abnormal 64.13 39.93 17 3462 698 2353908
Dysphagia 63.96 39.93 37 3442 12768 2341838
Pneumonia aspiration 63.14 39.93 25 3454 3717 2350889
Desmoplastic small round cell tumour 62.92 39.93 9 3470 6 2354600
Epistaxis 61.82 39.93 33 3446 9746 2344860
Dyspnoea 60.46 39.93 77 3402 78656 2275950
Tumour haemorrhage 59.88 39.93 14 3465 340 2354266
Infection 59.43 39.93 40 3439 17989 2336617
Oral candidiasis 58.71 39.93 20 3459 1945 2352661
Abdominal pain 57.61 39.93 51 3428 34323 2320283
Hyponatraemia 57.40 39.93 35 3444 13290 2341316
Neutrophil count abnormal 56.63 39.93 14 3465 433 2354173
Acute myeloid leukaemia 56.05 39.93 21 3458 2689 2351917
Metastatic malignant melanoma 55.55 39.93 13 3466 317 2354289
Mucosal inflammation 55.10 39.93 25 3454 5199 2349407
Candida infection 54.86 39.93 21 3458 2852 2351754
Brain neoplasm 52.05 39.93 15 3464 841 2353765
Pleural effusion 51.15 39.93 31 3448 11637 2342969
Tumour pseudoprogression 50.76 39.93 9 3470 49 2354557
Recurrent cancer 50.11 39.93 12 3467 324 2354282
Blood alkaline phosphatase increased 49.73 39.93 25 3454 6520 2348086
C-reactive protein increased 47.84 39.93 24 3455 6231 2348375
Vasogenic cerebral oedema 47.64 39.93 9 3470 73 2354533
Oedema 47.03 39.93 28 3451 10175 2344431
Aspergillus infection 45.99 39.93 14 3465 949 2353657
Haemoglobin abnormal 45.94 39.93 13 3466 682 2353924
Cytomegalovirus infection 45.32 39.93 18 3461 2695 2351911
Cognitive disorder 45.17 39.93 22 3457 5359 2349247
Hemiplegia 44.72 39.93 15 3464 1390 2353216
Pneumonitis 44.72 39.93 20 3459 4019 2350587
Brain neoplasm malignant 44.66 39.93 10 3469 199 2354407
Aphasia 43.94 39.93 21 3458 4907 2349699
Stevens-Johnson syndrome 43.70 39.93 20 3459 4239 2350367
Haematocrit decreased 43.44 39.93 20 3459 4298 2350308
Weight decreased 43.38 39.93 40 3439 28331 2326275
Gait disturbance 42.91 39.93 36 3443 22509 2332097
Haemorrhage 42.48 39.93 27 3452 11012 2343594
Blood potassium decreased 42.47 39.93 21 3458 5284 2349322
Pruritus 42.38 39.93 48 3431 43292 2311314
Intracranial tumour haemorrhage 42.34 39.93 8 3471 65 2354541
Bronchopulmonary aspergillosis 41.22 39.93 13 3466 991 2353615
Depressed level of consciousness 40.70 39.93 23 3456 7581 2347025
Haematoma 40.19 39.93 20 3459 5101 2349505

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 961.93 39.43 321 3439 16942 1726079
Thrombocytopenia 645.65 39.43 253 3507 20996 1722025
Malignant neoplasm progression 412.25 39.43 164 3596 13994 1729027
Lymphopenia 382.97 39.43 98 3662 1935 1741086
Glioblastoma multiforme 350.49 39.43 63 3697 184 1742837
Pulmonary embolism 347.84 39.43 142 3618 12917 1730104
Nausea 344.99 39.43 219 3541 50977 1692044
Platelet count decreased 338.22 39.43 149 3611 16374 1726647
Seizure 320.09 39.43 153 3607 20288 1722733
Pancytopenia 307.40 39.43 125 3635 11232 1731789
Glioblastoma 306.97 39.43 58 3702 240 1742781
Pneumonia 296.83 39.43 192 3568 45990 1697031
Lymphocyte count decreased 294.79 39.43 81 3679 2117 1740904
Neoplasm progression 293.07 39.43 88 3672 3179 1739842
Vomiting 267.47 39.43 168 3592 38147 1704874
Bone marrow failure 245.16 39.43 86 3674 5114 1737907
Confusional state 232.41 39.43 125 3635 21153 1721868
Brain oedema 226.75 39.43 66 3694 2130 1740891
Deep vein thrombosis 217.21 39.43 94 3666 9826 1733195
Alanine aminotransferase increased 213.49 39.43 99 3661 12179 1730842
Pyrexia 206.00 39.43 154 3606 46246 1696775
Drug ineffective 204.99 39.43 175 3585 63626 1679395
Neutropenia 195.66 39.43 106 3654 18154 1724867
Product use in unapproved indication 195.54 39.43 86 3674 9336 1733685
Death 194.13 39.43 195 3565 87248 1655773
Asthenia 192.58 39.43 132 3628 34538 1708483
White blood cell count decreased 191.86 39.43 94 3666 13055 1729966
Sepsis 184.00 39.43 104 3656 19334 1723687
Off label use 173.09 39.43 129 3631 38442 1704579
Pneumocystis jirovecii pneumonia 172.93 39.43 55 3705 2401 1740620
Febrile neutropenia 169.81 39.43 82 3678 11018 1732003
General physical health deterioration 156.83 39.43 82 3678 13036 1729985
Aphasia 154.42 39.43 55 3705 3406 1739615
Dehydration 152.35 39.43 89 3671 17569 1725452
Aspartate aminotransferase increased 142.28 39.43 72 3688 10684 1732337
Hemiparesis 139.40 39.43 48 3712 2686 1740335
Fatigue 137.98 39.43 127 3633 50654 1692367
Hyperglycaemia 136.41 39.43 56 3704 5109 1737912
Disease recurrence 134.24 39.43 46 3714 2536 1740485
Constipation 127.70 39.43 75 3685 14925 1728096
Anaemia 121.84 39.43 94 3666 29363 1713658
Blood lactate dehydrogenase increased 114.86 39.43 45 3715 3630 1739391
Hepatic function abnormal 113.33 39.43 54 3706 7020 1736001
Headache 113.17 39.43 96 3664 34280 1708741
Decreased appetite 111.57 39.43 82 3678 23789 1719232
Fall 110.65 39.43 86 3674 27128 1715893
Hydrocephalus 106.26 39.43 30 3730 862 1742159
Leukopenia 104.04 39.43 54 3706 8426 1734595
Intracranial tumour haemorrhage 102.00 39.43 19 3741 71 1742950
Cholestasis 101.04 39.43 41 3719 3624 1739397
Aplastic anaemia 93.38 39.43 26 3734 709 1742312
Gait disturbance 91.37 39.43 57 3703 12613 1730408
Diarrhoea 88.54 39.43 103 3657 53749 1689272
Neoplasm recurrence 87.72 39.43 22 3738 395 1742626
Anaplastic astrocytoma 84.49 39.43 14 3746 20 1743001
Neutrophil count decreased 84.09 39.43 42 3718 6039 1736982
Hepatitis 79.84 39.43 38 3722 4917 1738104
Gamma-glutamyltransferase increased 78.81 39.43 38 3722 5060 1737961
Infection 75.25 39.43 50 3710 12310 1730711
Dysphagia 71.40 39.43 45 3715 10123 1732898
Brain neoplasm 68.37 39.43 20 3740 653 1742368
Magnetic resonance imaging brain abnormal 67.07 39.43 17 3743 319 1742702
Brain neoplasm malignant 66.62 39.43 15 3745 165 1742856
Recurrent cancer 65.69 39.43 16 3744 253 1742768
Mental status changes 64.06 39.43 35 3725 6040 1736981
Cerebral haemorrhage 62.99 39.43 35 3725 6242 1736779
Pneumonitis 62.98 39.43 30 3730 3885 1739136
Acute respiratory distress syndrome 62.64 39.43 29 3731 3522 1739499
Mucosal inflammation 61.19 39.43 30 3730 4139 1738882
Cognitive disorder 60.11 39.43 30 3730 4300 1738721
Hypophagia 59.95 39.43 28 3732 3469 1739552
Septic shock 59.71 39.43 37 3723 8072 1734949
Condition aggravated 59.24 39.43 54 3706 21096 1721925
Febrile bone marrow aplasia 59.01 39.43 19 3741 859 1742162
Hepatocellular injury 58.91 39.43 27 3733 3204 1739817
Muscular weakness 58.85 39.43 40 3720 10209 1732812
Petechiae 58.77 39.43 22 3738 1563 1741458
C-reactive protein increased 56.83 39.43 32 3728 5853 1737168
Epilepsy 56.64 39.43 28 3732 3931 1739090
Abdominal pain 56.56 39.43 53 3707 21437 1721584
Jaundice 55.94 39.43 32 3728 6030 1736991
Metastases to lung 55.80 39.43 21 3739 1514 1741507
Respiratory failure 54.83 39.43 44 3716 14461 1728560
Pneumonia aspiration 54.58 39.43 30 3730 5236 1737785
Haemoglobin decreased 54.49 39.43 47 3713 17067 1725954
Tumour haemorrhage 53.54 39.43 16 3744 563 1742458
Agranulocytosis 53.27 39.43 26 3734 3550 1739471
Urinary incontinence 50.30 39.43 23 3737 2713 1740308
Metastases to meninges 49.68 39.43 13 3747 278 1742743
Acute kidney injury 49.32 39.43 62 3698 34882 1708139
Metastatic malignant melanoma 48.76 39.43 14 3746 427 1742594
Chills 47.47 39.43 37 3723 11650 1731371
Blood albumin decreased 47.32 39.43 19 3741 1629 1741392
Hypokalaemia 46.70 39.43 29 3731 6345 1736676
Blood glucose increased 46.26 39.43 35 3725 10549 1732472
Somnolence 45.40 39.43 42 3718 16697 1726324
Diabetes insipidus 44.89 39.43 13 3747 409 1742612
Blood bilirubin increased 44.85 39.43 28 3732 6182 1736839
Liver disorder 44.75 39.43 27 3733 5609 1737412
Pneumocystis jirovecii infection 44.46 39.43 12 3748 290 1742731
Blood alkaline phosphatase increased 44.15 39.43 26 3734 5169 1737852
Deafness 44.09 39.43 19 3741 1947 1741074
Ataxia 43.94 39.43 20 3740 2333 1740688
Weight decreased 43.13 39.43 47 3713 22706 1720315
Urinary tract infection 43.10 39.43 33 3727 10120 1732901
Paraparesis 43.05 39.43 12 3748 328 1742693
Inappropriate schedule of product administration 42.53 39.43 29 3731 7430 1735591
Hyponatraemia 42.08 39.43 31 3729 8969 1734052
Unmasking of previously unidentified disease 41.80 39.43 9 3751 79 1742942
Generalised tonic-clonic seizure 41.78 39.43 23 3737 4023 1738998
Glioma 41.60 39.43 9 3751 81 1742940
Strongyloidiasis 40.26 39.43 12 3748 418 1742603
Hippocampal sclerosis 39.83 39.43 7 3753 17 1743004
Therapy non-responder 39.66 39.43 26 3734 6240 1736781

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
CHEBI has role CHEBI:35610 antineoplastic agent
CHEBI has role CHEBI:50266 prodrug
MeSH PA D000970 Antineoplastic Agents
MeSH PA D018906 Antineoplastic Agents, Alkylating
MeSH PA D009676 Noxae

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1366 CAPSULE 100 mg ORAL NDA 19 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1381 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 2.50 mg INTRAVENOUS NDA 19 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1417 CAPSULE 250 mg ORAL NDA 19 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1425 CAPSULE 140 mg ORAL NDA 19 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1430 CAPSULE 180 mg ORAL NDA 19 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-1519 CAPSULE 20 mg ORAL NDA 19 sections
TEMODAR HUMAN PRESCRIPTION DRUG LABEL 1 0085-3004 CAPSULE 5 mg ORAL NDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7599 CAPSULE 5 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7600 CAPSULE 20 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7601 CAPSULE 100 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7602 CAPSULE 250 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7638 CAPSULE 140 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0093-7639 CAPSULE 180 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1777 CAPSULE 5 mg ORAL ANDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1778 CAPSULE 20 mg ORAL ANDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1779 CAPSULE 100 mg ORAL ANDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1780 CAPSULE 140 mg ORAL ANDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1781 CAPSULE 180 mg ORAL ANDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0527-1782 CAPSULE 250 mg ORAL ANDA 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2691 CAPSULE 5 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2692 CAPSULE 20 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2693 CAPSULE 100 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2694 CAPSULE 140 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2695 CAPSULE 180 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 0781-2696 CAPSULE 250 mg ORAL NDA AUTHORIZED GENERIC 19 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-048 CAPSULE 5 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-049 CAPSULE 20 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-050 CAPSULE 100 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-051 CAPSULE 250 mg ORAL ANDA 18 sections
Temozolomide HUMAN PRESCRIPTION DRUG LABEL 1 16729-129 CAPSULE 140 mg ORAL ANDA 18 sections