thiotepa 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
antineoplastics, thiotepa derivatives 2638 52-24-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • thio-tepa
  • triethylenethiophosphortriamide
  • thiotepa
  • oncotepa
  • phosphorothioic acid triethylenetriamide
  • tespamin
  • tespamine
  • thiophosphamide
  • tepadina
A very toxic alkylating antineoplastic agent also used as an insect sterilant. It causes skin, gastrointestinal, CNS, and bone marrow damage. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), thiotepa may reasonably be anticipated to be a carcinogen (Merck Index, 11th ed).
  • Molecular weight: 189.22
  • Formula: C6H12N3PS
  • CLOGP: 0.52
  • LIPINSKI: 0
  • HAC: 3
  • HDO: 0
  • TPSA: 9.03
  • ALOGS: -1.31
  • ROTB: 3

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 1 Hosey CM, Chan R, Benet LZ
Vd (Volume of distribution) 1.60 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 6.70 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.90 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2.70 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
March 26, 2019 PMDA Sumitomo Dainippon Pharma
March 26, 2021 EMA RIEMSER Pharma GmbH
March 9, 1959 FDA

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
Mucosal inflammation 407.64 38.97 157 5502 39985 50559480
Acute graft versus host disease 400.18 38.97 92 5567 3866 50595599
Human herpesvirus 6 infection 370.06 38.97 80 5579 2526 50596939
Cytomegalovirus infection 329.36 38.97 109 5550 17853 50581612
Graft versus host disease in skin 234.83 38.97 55 5604 2501 50596964
Chronic graft versus host disease 223.41 38.97 54 5605 2813 50596652
Venoocclusive liver disease 206.92 38.97 55 5604 4206 50595259
Acute graft versus host disease in skin 195.47 38.97 49 5610 2969 50596496
Encephalitis viral 193.15 38.97 43 5616 1554 50597911
Graft versus host disease 191.20 38.97 56 5603 6110 50593355
Febrile neutropenia 184.44 38.97 122 5537 97545 50501920
Product use in unapproved indication 183.99 38.97 130 5529 115689 50483776
Haematotoxicity 181.72 38.97 57 5602 7838 50591627
Pre-engraftment immune reaction 173.92 38.97 29 5630 209 50599256
Adenovirus infection 173.53 38.97 45 5614 3123 50596342
Cytomegalovirus infection reactivation 171.80 38.97 43 5616 2588 50596877
Cytomegalovirus viraemia 160.33 38.97 46 5613 4663 50594802
Thrombotic microangiopathy 139.82 38.97 48 5611 8743 50590722
Graft versus host disease in gastrointestinal tract 126.02 38.97 34 5625 2747 50596718
Bacterial sepsis 112.80 38.97 33 5626 3579 50595886
Acute graft versus host disease in intestine 108.05 38.97 27 5632 1612 50597853
Acute lymphocytic leukaemia recurrent 98.26 38.97 26 5633 1949 50597516
Neutropenia 97.07 38.97 100 5559 147865 50451600
Transplant dysfunction 92.04 38.97 30 5629 4654 50594811
Epstein-Barr virus infection 91.36 38.97 33 5626 6964 50592501
Thrombocytopenia 90.49 38.97 90 5569 127583 50471882
Venoocclusive disease 89.76 38.97 24 5635 1872 50597593
Posterior reversible encephalopathy syndrome 88.86 38.97 40 5619 14888 50584577
BK virus infection 75.54 38.97 23 5636 2858 50596607
Sepsis 73.30 38.97 82 5577 132843 50466622
Neurotoxicity 70.65 38.97 34 5625 14706 50584759
Viral haemorrhagic cystitis 69.38 38.97 16 5643 677 50598788
Transplant failure 67.17 38.97 18 5641 1415 50598050
Cystitis haemorrhagic 65.86 38.97 22 5637 3680 50595785
Neoplasm recurrence 62.48 38.97 19 5640 2350 50597115
Meningoencephalitis herpetic 62.44 38.97 16 5643 1056 50598409
Toxic erythema of chemotherapy 61.37 38.97 11 5648 126 50599339
Bacteraemia 59.36 38.97 30 5629 14403 50585062
Cytomegalovirus chorioretinitis 57.04 38.97 16 5643 1491 50597974
Hypogonadism female 56.70 38.97 8 5651 14 50599451
Post transplant lymphoproliferative disorder 55.51 38.97 20 5639 4184 50595281
Progressive multifocal leukoencephalopathy 53.60 38.97 26 5633 11431 50588034
Pyrexia 52.93 38.97 125 5534 380078 50219387
Viraemia 52.74 38.97 14 5645 1061 50598404
Multiple organ dysfunction syndrome 52.24 38.97 44 5615 50293 50549172
Fatigue 51.00 38.97 9 5650 707592 49891873
Off label use 47.62 38.97 138 5521 474288 50125177
Stem cell transplant 46.66 38.97 14 5645 1654 50597811
Leukaemia recurrent 46.04 38.97 13 5646 1241 50598224
Leukoencephalopathy 45.80 38.97 17 5642 3866 50595599
Pulmonary vascular disorder 45.34 38.97 10 5649 345 50599120
Pulmonary arterial hypertension 44.65 38.97 28 5631 20291 50579174
Alveolar soft part sarcoma 44.06 38.97 8 5651 99 50599366
Dyspnoea 43.99 38.97 5 5654 547603 50051862
Osteosarcoma 42.57 38.97 8 5651 121 50599344
Skin toxicity 42.04 38.97 16 5643 3897 50595568
Lower respiratory tract infection fungal 41.52 38.97 9 5650 286 50599179
JC virus infection 41.29 38.97 13 5646 1802 50597663
Polyomavirus-associated nephropathy 39.02 38.97 12 5647 1540 50597925

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
Mucosal inflammation 425.90 33.66 185 6526 31410 29536406
Cytomegalovirus infection 365.95 33.66 152 6559 23063 29544753
Acute graft versus host disease 330.35 33.66 99 6612 5725 29562091
Acute graft versus host disease in skin 315.99 33.66 91 6620 4573 29563243
Acute graft versus host disease in intestine 243.49 33.66 64 6647 2277 29565539
Human herpesvirus 6 infection 242.98 33.66 61 6650 1802 29566014
Venoocclusive liver disease 240.48 33.66 81 6630 6836 29560980
Graft versus host disease in skin 224.67 33.66 65 6646 3314 29564502
Adenovirus infection 207.06 33.66 65 6646 4382 29563434
Graft versus host disease in gastrointestinal tract 187.30 33.66 56 6655 3202 29564614
Febrile neutropenia 166.47 33.66 163 6548 112077 29455739
Epstein-Barr virus infection 159.24 33.66 59 6652 6570 29561246
Cytomegalovirus infection reactivation 155.87 33.66 49 6662 3315 29564501
Chronic graft versus host disease 147.18 33.66 49 6662 3980 29563836
Graft versus host disease 131.32 33.66 57 6654 9571 29558245
Venoocclusive disease 130.30 33.66 40 6671 2499 29565317
Haematotoxicity 122.87 33.66 49 6662 6650 29561166
Product use in unapproved indication 119.04 33.66 121 6590 86754 29481062
Pulmonary vascular disorder 96.05 33.66 23 6688 554 29567262
Viral haemorrhagic cystitis 94.36 33.66 25 6686 915 29566901
Pulmonary arterial hypertension 91.54 33.66 41 6670 7408 29560408
Cystitis haemorrhagic 90.81 33.66 36 6675 4806 29563010
Cytomegalovirus viraemia 88.06 33.66 38 6673 6282 29561534
Post transplant lymphoproliferative disorder 86.41 33.66 36 6675 5457 29562359
Thrombotic microangiopathy 85.54 33.66 41 6670 8640 29559176
Posterior reversible encephalopathy syndrome 81.24 33.66 40 6671 8936 29558880
Engraftment syndrome 77.89 33.66 21 6690 822 29566994
Encephalitis viral 71.77 33.66 21 6690 1111 29566705
BK virus infection 71.19 33.66 30 6681 4677 29563139
Pulmonary arteriopathy 71.11 33.66 13 6698 76 29567740
Autoimmune lymphoproliferative syndrome 68.90 33.66 14 6697 152 29567664
Graft versus host disease in liver 68.20 33.66 20 6691 1066 29566750
Parainfluenzae virus infection 65.14 33.66 23 6688 2226 29565590
Thrombocytopenia 64.43 33.66 112 6599 134711 29433105
Multiple organ dysfunction syndrome 63.77 33.66 75 6636 63041 29504775
Juvenile melanoma benign 59.23 33.66 11 6700 71 29567745
Off label use 57.93 33.66 174 6537 300626 29267190
Pre-engraftment immune reaction 57.16 33.66 11 6700 88 29567728
Cytomegalovirus chorioretinitis 53.55 33.66 22 6689 3216 29564600
Chronic graft versus host disease in skin 50.99 33.66 15 6696 808 29567008
Pneumonia cytomegaloviral 50.48 33.66 20 6691 2662 29565154
Myelitis transverse 48.64 33.66 15 6696 950 29566866
Acute graft versus host disease in liver 47.76 33.66 16 6695 1322 29566494
Idiopathic pneumonia syndrome 47.18 33.66 11 6700 235 29567581
Autoimmune haemolytic anaemia 46.69 33.66 21 6690 3827 29563989
Fatigue 46.63 33.66 8 6703 316813 29251003
Neutropenia 46.24 33.66 96 6615 131615 29436201
Bacterial sepsis 45.67 33.66 22 6689 4681 29563135
Bronchiolitis obliterans syndrome 45.62 33.66 10 6701 160 29567656
Respiratory syncytial virus infection 44.49 33.66 20 6691 3639 29564177
Sepsis 44.36 33.66 99 6612 142583 29425233
Osteosarcoma 43.86 33.66 10 6701 193 29567623
NPM1 gene mutation 42.80 33.66 9 6702 117 29567699
Dyspnoea 42.45 33.66 11 6700 326721 29241095
CNS ventriculitis 42.44 33.66 10 6701 224 29567592
Bone marrow failure 40.70 33.66 40 6671 27409 29540407
Encephalitis cytomegalovirus 39.57 33.66 11 6700 483 29567333
Aplasia 39.43 33.66 19 6692 4044 29563772
Chimerism 37.37 33.66 9 6702 222 29567594
Bone sarcoma 35.06 33.66 7 6704 69 29567747
Leukoencephalopathy 34.71 33.66 17 6694 3750 29564066
Angiodysplasia 34.62 33.66 10 6701 505 29567311

FDA Adverse Event Reporting System (Geriatric)

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
Cytomegalovirus infection 742.52 30.04 274 11785 36925 64449748
Mucosal inflammation 678.62 30.04 297 11762 62287 64424386
Acute graft versus host disease in skin 648.69 30.04 167 11892 6688 64479985
Acute graft versus host disease 583.73 30.04 163 11896 8921 64477752
Human herpesvirus 6 infection 547.61 30.04 135 11924 4519 64482154
Graft versus host disease in skin 451.33 30.04 119 11940 5228 64481445
Venoocclusive liver disease 436.58 30.04 133 11926 9882 64476791
Adenovirus infection 428.86 30.04 122 11937 7133 64479540
Acute graft versus host disease in intestine 385.97 30.04 97 11962 3512 64483161
Febrile neutropenia 356.06 30.04 288 11771 187369 64299304
Cytomegalovirus infection reactivation 341.09 30.04 97 11962 5659 64481014
Graft versus host disease 332.30 30.04 117 11942 13696 64472977
Graft versus host disease in gastrointestinal tract 307.58 30.04 89 11970 5523 64481150
Product use in unapproved indication 301.33 30.04 255 11804 176363 64310310
Haematotoxicity 294.11 30.04 105 11954 12791 64473882
Epstein-Barr virus infection 282.23 30.04 101 11958 12387 64474286
Chronic graft versus host disease 267.68 30.04 82 11977 6194 64480479
Encephalitis viral 254.60 30.04 64 11995 2316 64484357
Venoocclusive disease 244.40 30.04 69 11990 3916 64482757
Cytomegalovirus viraemia 238.74 30.04 86 11973 10742 64475931
Pre-engraftment immune reaction 217.79 30.04 40 12019 301 64486372
Thrombotic microangiopathy 196.16 30.04 84 11975 16571 64470102
Viral haemorrhagic cystitis 170.08 30.04 43 12016 1592 64485081
BK virus infection 163.85 30.04 59 12000 7353 64479320
Bacterial sepsis 159.76 30.04 58 12001 7399 64479274
Cystitis haemorrhagic 148.79 30.04 56 12003 7900 64478773
Pulmonary vascular disorder 140.37 30.04 33 12026 896 64485777
Posterior reversible encephalopathy syndrome 135.55 30.04 72 11987 22874 64463799
Post transplant lymphoproliferative disorder 135.46 30.04 55 12004 9489 64477184
Pulmonary arterial hypertension 120.66 30.04 69 11990 25298 64461375
Multiple organ dysfunction syndrome 106.25 30.04 112 11947 101301 64385372
Sepsis 105.78 30.04 169 11890 230172 64256501
Chronic graft versus host disease in skin 103.30 30.04 28 12031 1363 64485310
Fatigue 101.70 30.04 11 12048 748719 63737954
Engraftment syndrome 99.76 30.04 26 12033 1087 64485586
Autoimmune haemolytic anaemia 97.75 30.04 40 12019 7036 64479637
Transplant dysfunction 96.36 30.04 39 12020 6669 64480004
Acute lymphocytic leukaemia recurrent 96.35 30.04 34 12025 3992 64482681
Off label use 94.15 30.04 295 11764 632511 63854162
Thrombocytopenia 93.00 30.04 157 11902 223644 64263029
Pulmonary arteriopathy 90.83 30.04 16 12043 92 64486581
Dyspnoea 89.31 30.04 14 12045 718660 63768013
Neutropenia 89.03 30.04 160 11899 239464 64247209
Osteosarcoma 85.60 30.04 18 12041 288 64486385
Acute graft versus host disease in liver 80.31 30.04 24 12035 1663 64485010
Respiratory syncytial virus infection 80.11 30.04 35 12024 7233 64479440
Cytomegalovirus chorioretinitis 79.05 30.04 31 12028 4881 64481792
Transplant failure 72.00 30.04 27 12032 3767 64482906
Autoimmune lymphoproliferative syndrome 70.09 30.04 14 12045 171 64486502
Arthralgia 70.00 30.04 3 12056 442257 64044416
Leukoencephalopathy 68.60 30.04 31 12028 6936 64479737
Neoplasm recurrence 65.15 30.04 25 12034 3714 64482959
Graft versus host disease in liver 65.11 30.04 20 12039 1521 64485152
Pneumonia cytomegaloviral 64.99 30.04 26 12033 4313 64482360
Pyrexia 64.89 30.04 240 11819 558404 63928269
Neurotoxicity 64.59 30.04 48 12011 27356 64459317
Metaplasia 64.12 30.04 15 12044 398 64486275
Parainfluenzae virus infection 62.75 30.04 26 12033 4717 64481956
Focal nodular hyperplasia 62.05 30.04 16 12043 641 64486032
Pain 61.82 30.04 14 12045 553497 63933176
Skin toxicity 60.67 30.04 28 12031 6574 64480099
Myelitis transverse 59.92 30.04 19 12040 1604 64485069
Stem cell transplant 59.67 30.04 23 12036 3458 64483215
Dizziness 59.08 30.04 6 12053 430157 64056516
Leukaemia recurrent 58.63 30.04 21 12038 2573 64484100
Epstein-Barr viraemia 58.02 30.04 19 12040 1778 64484895
Bone marrow failure 57.49 30.04 57 12002 47895 64438778
Toxic erythema of chemotherapy 55.52 30.04 12 12047 220 64486453
Meningoencephalitis herpetic 54.37 30.04 18 12041 1743 64484930
Bacteraemia 54.35 30.04 43 12016 26868 64459805
Hepatotoxicity 52.59 30.04 50 12009 39912 64446761
Hypogonadism female 52.59 30.04 8 12051 14 64486659
Aplasia 50.24 30.04 25 12034 6928 64479745
Rhinovirus infection 50.07 30.04 24 12035 6132 64480541
Idiopathic pneumonia syndrome 50.05 30.04 13 12046 536 64486137
NPM1 gene mutation 49.49 30.04 10 12049 130 64486543
Bronchiolitis obliterans syndrome 48.53 30.04 11 12048 253 64486420
Gastroenteritis adenovirus 48.32 30.04 11 12048 258 64486415
Mucosal toxicity 46.55 30.04 12 12047 480 64486193
Bone sarcoma 46.52 30.04 9 12050 92 64486581
Viraemia 45.60 30.04 17 12042 2332 64484341
Toxoplasmosis 44.95 30.04 17 12042 2427 64484246
Pruritus 43.81 30.04 4 12055 312396 64174277
Nausea 43.42 30.04 50 12009 785750 63700923
Chimerism 42.72 30.04 10 12049 266 64486407
Disseminated toxoplasmosis 42.56 30.04 9 12050 148 64486525
Encephalitis cytomegalovirus 42.27 30.04 13 12046 992 64485681
Pulmonary veno-occlusive disease 41.71 30.04 14 12045 1414 64485259
Multisystem inflammatory syndrome in children 40.56 30.04 7 12052 35 64486638
Headache 39.82 30.04 25 12034 529442 63957231
Second primary malignancy 39.31 30.04 26 12033 12311 64474362
Herpes simplex reactivation 37.48 30.04 9 12050 268 64486405
Malaise 36.91 30.04 14 12045 396233 64090440
Asthenia 36.86 30.04 17 12042 428027 64058646
Premature menopause 35.99 30.04 10 12049 534 64486139
Acute myeloid leukaemia recurrent 35.94 30.04 15 12044 2769 64483904
Herpes simplex 35.51 30.04 23 12036 10513 64476160
Bacille Calmette-Guerin scar reactivation 34.77 30.04 6 12053 30 64486643
Cerebral toxoplasmosis 34.66 30.04 13 12046 1813 64484860
Alveolar soft part sarcoma 34.50 30.04 7 12052 93 64486580
Myelodysplastic syndrome 33.45 30.04 33 12026 27546 64459127
Pneumocystis jirovecii pneumonia 33.39 30.04 33 12026 27601 64459072
Acute respiratory distress syndrome 32.12 30.04 38 12021 38897 64447776
Angiodysplasia 31.83 30.04 10 12049 819 64485854
Chronic graft versus host disease in intestine 31.82 30.04 8 12051 289 64486384
Pain in extremity 31.20 30.04 9 12050 303076 64183597
Chronic graft versus host disease in liver 31.02 30.04 9 12050 562 64486111
CNS ventriculitis 30.68 30.04 8 12051 335 64486338
Weight decreased 30.32 30.04 8 12051 285731 64200942
Condition aggravated 30.22 30.04 16 12043 372410 64114263

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01AC01 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ALKYLATING AGENTS
Ethylene imines
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 D007155 Immunologic Factors
MeSH PA D007166 Immunosuppressive Agents
MeSH PA D019653 Myeloablative Agonists
MeSH PA D009676 Noxae

Drug Use | Suggest Off label Use Form| |View source of the data|

DiseaseRelationSNOMED_IDDOID
Allogeneic bone marrow transplantation indication 58390007
Hodgkin's disease indication 118599009
Malignant lymphoma indication 118600007 DOID:0060058
Non-Hodgkin's lymphoma indication 118601006
Malignant tumor of ovary indication 363443007 DOID:2394
Malignant tumor of urinary bladder indication 399326009 DOID:11054
Carcinoma of female breast indication 447782002
Pleural Malignant Effusions indication
Peritoneal Malignant Effusions indication
Pericardial Malignant Effusions indication
Acute infectious disease contraindication 63171007
Blood coagulation disorder contraindication 64779008 DOID:1247
Leukopenia contraindication 84828003 DOID:615
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Bone marrow depression contraindication 307762000
Breastfeeding (mother) contraindication 413712001




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

None

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
100MG/VIAL TEPADINA ADIENNE SA N208264 Jan. 26, 2017 RX POWDER INTRACAVITARY, INTRAVENOUS, INTRAVESICAL Jan. 26, 2024 INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA
15MG/VIAL TEPADINA ADIENNE SA N208264 Jan. 26, 2017 RX POWDER INTRACAVITARY, INTRAVENOUS, INTRAVESICAL Jan. 26, 2024 INDICATED FOR REDUCING THE RISK OF GRAFT REJECTION WHEN USED IN CONJUNCTION WITH HIGH-DOSE BUSULFAN & CYCLOPHOSPHAMIDE AS A PREPARATIVE REGIMEN FOR ALLOGENIC HEMATOPOIETIC PROGENITOR CELL TRANSPLANTATION FOR PEDS. PATIENTS WITH CLASS 3 BETA-THALASSEMIA

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Cytochrome P450 2B6 Enzyme INHIBITOR Ki 5.32 IUPHAR

External reference:

IDSource
4017910 VUID
N0000146261 NUI
D00583 KEGG_DRUG
4017910 VANDF
C0039871 UMLSCUI
CHEBI:9570 CHEBI
CHEMBL671 ChEMBL_ID
D013852 MESH_DESCRIPTOR_UI
DB04572 DRUGBANK_ID
7622 IUPHAR_LIGAND_ID
881 INN_ID
905Z5W3GKH UNII
5453 PUBCHEM_CID
10473 RXNORM
184712 MMSL
2134 MMSL
5573 MMSL
d00390 MMSL
002637 NDDF
387508004 SNOMEDCT_US
88997008 SNOMEDCT_US

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 0143-9309 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRACAVITARY ANDA 22 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 0143-9565 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRACAVITARY ANDA 22 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 25021-246 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 23 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 43598-650 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 20 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 54879-014 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRACAVITARY ANDA 23 sections
Thiotepa HUMAN PRESCRIPTION DRUG LABEL 1 65219-029 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 27 sections
Thiotepa Human Prescription Drug Label 1 68083-446 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 27 sections
Thiotepa Human Prescription Drug Label 1 68083-503 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 27 sections
Thiotepa Human Prescription Drug Label 1 69539-123 INJECTION, POWDER, FOR SOLUTION 15 mg INTRAVENOUS ANDA 25 sections
Thiotepa Human Prescription Drug Label 1 69539-124 INJECTION, POWDER, FOR SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1630 INJECTION, POWDER, FOR SOLUTION 15 mg INTRACAVITARY NDA 18 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1630 INJECTION, POWDER, FOR SOLUTION 15 mg INTRACAVITARY NDA 18 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1631 INJECTION, POWDER, FOR SOLUTION 100 mg INTRACAVITARY NDA 18 sections
TEPADINA HUMAN PRESCRIPTION DRUG LABEL 1 70121-1631 INJECTION, POWDER, FOR SOLUTION 100 mg INTRACAVITARY NDA 18 sections
Thiotepa Human Prescription Drug Label 1 72205-045 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 15 mg INTRAVENOUS ANDA 25 sections
Thiotepa Human Prescription Drug Label 1 72205-046 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 25 sections