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mitomycin 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| antineoplastics, nucleotoxic agents | 1819 | 50-07-7 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
An antineoplastic antibiotic produced by Streptomyces caespitosus. It is one of the bi- or tri-functional ALKYLATING AGENTS causing cross-linking of DNA and inhibition of DNA synthesis.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.50 mg/mL | Bocci G, Oprea TI, Benet LZ |
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 1 | Bocci G, Oprea TI, Benet LZ |
| fu (Fraction unbound in plasma) | 0.79 % | Kawashima H, Watanabe R, Esaki T, Kuroda M, Nagao C, Natsume-Kitatani Y, Ohashi R, Komura H, Mizuguchi K |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ACVR2A,ACVR2B,ACVRL1,AKT2,AKT3,ALK,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,ITK,JAK2,JAK3,KIT,MAP2K6,MAP3K14,MAP3K21,MAP3K7,MAP4K1,MAPK10,MAPK7,MAPK9,MAPKAPK2,MARK4,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CA,PIK3CB,PIK3CD,PIM2,PLK1,PLK2,PLK3,PLK4,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1 | 61 | |||
| kinase-selectivity-class | ACVR2B,AXL,CAMK2D,CDK16,CDK4,CDK9,CLK2,CLK4,EIF2AK3,GRK2,GSK3A,IKBKB,IRAK1,JAK2,JAK3,MAP2K6,MAP3K14,MAP3K7,MAPK7,PDK1,PIM3,SIK2,STK33,TEK,TTK,TYRO3,ULK1 | 27 | |||
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Aug. 24, 1981 | FDA | ||
| Dec. 23, 2022 | PMDA | Kyowa Kirin Co., Ltd. |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Pulmonary veno-occlusive disease | 171.58 | 34.76 | 31 | 2641 | 1507 | 90624268 |
| Conjunctival filtering bleb leak | 117.71 | 34.76 | 13 | 2659 | 6 | 90625769 |
| Off label use | 105.25 | 34.76 | 144 | 2528 | 1102108 | 89523667 |
| Haemolytic uraemic syndrome | 89.88 | 34.76 | 20 | 2652 | 2791 | 90622984 |
| Neutropenia | 83.81 | 34.76 | 62 | 2610 | 224842 | 90400933 |
| Iris transillumination defect | 76.03 | 34.76 | 11 | 2661 | 126 | 90625649 |
| Thrombocytopenia | 74.29 | 34.76 | 56 | 2616 | 208669 | 90417106 |
| Mucosal inflammation | 72.79 | 34.76 | 35 | 2637 | 57590 | 90568185 |
| Necrotising scleritis | 72.26 | 34.76 | 11 | 2661 | 182 | 90625593 |
| Disease progression | 71.73 | 34.76 | 49 | 2623 | 156566 | 90469209 |
| Radiation skin injury | 64.98 | 34.76 | 13 | 2659 | 1087 | 90624688 |
| Scleral thinning | 60.04 | 34.76 | 8 | 2664 | 47 | 90625728 |
| Malignant neoplasm progression | 60.00 | 34.76 | 38 | 2634 | 106832 | 90518943 |
| Leukopenia | 59.52 | 34.76 | 37 | 2635 | 100673 | 90525102 |
| Pancytopenia | 58.30 | 34.76 | 39 | 2633 | 120224 | 90505551 |
| Scleromalacia | 55.85 | 34.76 | 7 | 2665 | 23 | 90625752 |
| Arteriospasm coronary | 54.38 | 34.76 | 15 | 2657 | 5035 | 90620740 |
| Thrombotic microangiopathy | 52.06 | 34.76 | 19 | 2653 | 15724 | 90610051 |
| Bladder perforation | 50.61 | 34.76 | 8 | 2664 | 171 | 90625604 |
| Corneal epithelial microcysts | 47.15 | 34.76 | 6 | 2666 | 23 | 90625752 |
| Conjunctival erosion | 43.96 | 34.76 | 7 | 2665 | 157 | 90625618 |
| Eye infection toxoplasmal | 43.75 | 34.76 | 8 | 2664 | 414 | 90625361 |
| Extravasation | 42.30 | 34.76 | 11 | 2661 | 2953 | 90622822 |
| Tractional retinal detachment | 41.86 | 34.76 | 6 | 2666 | 64 | 90625711 |
| Hypotony of eye | 41.65 | 34.76 | 7 | 2665 | 221 | 90625554 |
| Panniculitis | 38.88 | 34.76 | 15 | 2657 | 14443 | 90611332 |
| Febrile neutropenia | 38.34 | 34.76 | 34 | 2638 | 158315 | 90467460 |
| Encapsulating peritoneal sclerosis | 38.25 | 34.76 | 7 | 2665 | 364 | 90625411 |
| Rhegmatogenous retinal detachment | 37.79 | 34.76 | 6 | 2666 | 132 | 90625643 |
| Diarrhoea | 37.51 | 34.76 | 84 | 2588 | 939106 | 89686669 |
| Acute promyelocytic leukaemia | 35.90 | 34.76 | 8 | 2664 | 1121 | 90624654 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Off label use | 126.31 | 30.14 | 168 | 2311 | 638167 | 41980689 |
| Scleral thinning | 97.78 | 30.14 | 12 | 2467 | 10 | 42618846 |
| Conjunctival filtering bleb leak | 91.51 | 30.14 | 11 | 2468 | 6 | 42618850 |
| Bladder perforation | 78.44 | 30.14 | 14 | 2465 | 314 | 42618542 |
| Iris hypopigmentation | 64.30 | 30.14 | 9 | 2470 | 36 | 42618820 |
| Post embolisation syndrome | 59.02 | 30.14 | 9 | 2470 | 72 | 42618784 |
| Hepatic artery occlusion | 56.68 | 30.14 | 9 | 2470 | 96 | 42618760 |
| NPM1 gene mutation | 55.04 | 30.14 | 9 | 2470 | 117 | 42618739 |
| Pancytopenia | 54.63 | 30.14 | 49 | 2430 | 117694 | 42501162 |
| Hepatic artery stenosis | 51.74 | 30.14 | 9 | 2470 | 173 | 42618683 |
| Chimerism | 48.60 | 30.14 | 9 | 2470 | 249 | 42618607 |
| Bronchiolitis obliterans syndrome | 46.92 | 30.14 | 9 | 2470 | 302 | 42618554 |
| Pulmonary veno-occlusive disease | 46.15 | 30.14 | 10 | 2469 | 620 | 42618236 |
| Bladder necrosis | 43.77 | 30.14 | 5 | 2474 | 0 | 42618856 |
| Scrotal ulcer | 42.64 | 30.14 | 9 | 2470 | 492 | 42618364 |
| Scleromalacia | 40.05 | 30.14 | 6 | 2473 | 42 | 42618814 |
| Dysuria | 34.86 | 30.14 | 22 | 2457 | 31074 | 42587782 |
| Gastric perforation | 34.45 | 30.14 | 11 | 2468 | 3082 | 42615774 |
| Disease progression | 34.41 | 30.14 | 42 | 2437 | 143614 | 42475242 |
| Conjunctival bleb | 34.04 | 30.14 | 5 | 2474 | 30 | 42618826 |
| Urinary tract toxicity | 33.25 | 30.14 | 5 | 2474 | 36 | 42618820 |
| Palmar-plantar erythrodysaesthesia syndrome | 32.04 | 30.14 | 18 | 2461 | 20564 | 42598292 |
| Metastases to central nervous system | 30.68 | 30.14 | 14 | 2465 | 10341 | 42608515 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Conjunctival filtering bleb leak | 205.36 | 26.76 | 24 | 5203 | 12 | 110584060 |
| Pulmonary veno-occlusive disease | 199.31 | 26.76 | 40 | 5187 | 2108 | 110581964 |
| Off label use | 186.89 | 26.76 | 285 | 4942 | 1499900 | 109084172 |
| Scleral thinning | 183.64 | 26.76 | 24 | 5203 | 65 | 110584007 |
| Scleromalacia | 139.90 | 26.76 | 19 | 5208 | 75 | 110583997 |
| Bladder perforation | 126.65 | 26.76 | 21 | 5206 | 373 | 110583699 |
| Pancytopenia | 108.15 | 26.76 | 85 | 5142 | 209528 | 110374544 |
| Hypotony of eye | 102.42 | 26.76 | 18 | 5209 | 457 | 110583615 |
| Disease progression | 92.83 | 26.76 | 83 | 5144 | 243951 | 110340121 |
| Mucosal inflammation | 84.44 | 26.76 | 54 | 5173 | 96087 | 110487985 |
| Iris hypopigmentation | 77.60 | 26.76 | 11 | 5216 | 63 | 110584009 |
| Hepatic artery stenosis | 76.14 | 26.76 | 13 | 5214 | 277 | 110583795 |
| Necrotising scleritis | 76.10 | 26.76 | 13 | 5214 | 278 | 110583794 |
| Radiation skin injury | 74.83 | 26.76 | 17 | 5210 | 1615 | 110582457 |
| Iris transillumination defect | 73.37 | 26.76 | 12 | 5215 | 195 | 110583877 |
| Neutropenia | 69.67 | 26.76 | 87 | 5140 | 374533 | 110209539 |
| Encapsulating peritoneal sclerosis | 67.40 | 26.76 | 14 | 5213 | 874 | 110583198 |
| Post embolisation syndrome | 66.19 | 26.76 | 10 | 5217 | 94 | 110583978 |
| Blebitis | 65.20 | 26.76 | 8 | 5219 | 10 | 110584062 |
| Haemolytic uraemic syndrome | 64.68 | 26.76 | 19 | 5208 | 4966 | 110579106 |
| Conjunctival erosion | 64.00 | 26.76 | 11 | 5216 | 244 | 110583828 |
| NPM1 gene mutation | 63.22 | 26.76 | 10 | 5217 | 130 | 110583942 |
| Thrombocytopenia | 60.06 | 26.76 | 78 | 5149 | 348807 | 110235265 |
| Hepatic artery occlusion | 57.72 | 26.76 | 9 | 5218 | 106 | 110583966 |
| Endophthalmitis | 55.40 | 26.76 | 19 | 5208 | 8168 | 110575904 |
| Conjunctival bleb | 55.15 | 26.76 | 9 | 5218 | 144 | 110583928 |
| Chimerism | 54.93 | 26.76 | 10 | 5217 | 311 | 110583761 |
| Leukopenia | 53.32 | 26.76 | 49 | 5178 | 148742 | 110435330 |
| Extravasation | 52.20 | 26.76 | 16 | 5211 | 4829 | 110579243 |
| Gastric perforation | 47.73 | 26.76 | 15 | 5212 | 4914 | 110579158 |
| Eosinophilic cystitis | 47.34 | 26.76 | 8 | 5219 | 160 | 110583912 |
| Bronchiolitis obliterans syndrome | 47.30 | 26.76 | 10 | 5217 | 680 | 110583392 |
| Bladder necrosis | 45.97 | 26.76 | 6 | 5221 | 16 | 110584056 |
| Scrotal ulcer | 45.46 | 26.76 | 9 | 5218 | 441 | 110583631 |
| Visual acuity reduced | 43.78 | 26.76 | 24 | 5203 | 32149 | 110551923 |
| Thrombotic microangiopathy | 43.17 | 26.76 | 23 | 5204 | 29126 | 110554946 |
| Pupillary disorder | 42.15 | 26.76 | 9 | 5218 | 642 | 110583430 |
| Acute promyelocytic leukaemia | 42.01 | 26.76 | 11 | 5216 | 1885 | 110582187 |
| Dysuria | 41.22 | 26.76 | 29 | 5198 | 60202 | 110523870 |
| Corneal epithelial microcysts | 41.16 | 26.76 | 6 | 5221 | 43 | 110584029 |
| Choroidal detachment | 40.62 | 26.76 | 9 | 5218 | 763 | 110583309 |
| Panniculitis | 40.30 | 26.76 | 18 | 5209 | 15564 | 110568508 |
| Arteriospasm coronary | 38.73 | 26.76 | 15 | 5212 | 9085 | 110574987 |
| Palmar-plantar erythrodysaesthesia syndrome | 38.37 | 26.76 | 24 | 5203 | 41001 | 110543071 |
| Eye infection toxoplasmal | 35.29 | 26.76 | 8 | 5219 | 752 | 110583320 |
| Tractional retinal detachment | 35.27 | 26.76 | 6 | 5221 | 125 | 110583947 |
| Chemical cystitis | 32.60 | 26.76 | 4 | 5223 | 5 | 110584067 |
| Hyphaema | 32.30 | 26.76 | 8 | 5219 | 1099 | 110582973 |
| Second primary malignancy | 31.76 | 26.76 | 16 | 5211 | 18052 | 110566020 |
| Acute myeloid leukaemia recurrent | 31.20 | 26.76 | 11 | 5216 | 5128 | 110578944 |
| Rhegmatogenous retinal detachment | 30.85 | 26.76 | 6 | 5221 | 268 | 110583804 |
| Anterior chamber pigmentation | 30.55 | 26.76 | 4 | 5223 | 11 | 110584061 |
| Pulmonary arterial hypertension | 30.32 | 26.76 | 19 | 5208 | 32549 | 110551523 |
| Diarrhoea | 29.61 | 26.76 | 119 | 5108 | 1139386 | 109444686 |
| Urinary tract toxicity | 28.68 | 26.76 | 4 | 5223 | 20 | 110584052 |
| Corneal oedema | 28.01 | 26.76 | 9 | 5218 | 3164 | 110580908 |
| Pollakiuria | 27.30 | 26.76 | 20 | 5207 | 44175 | 110539897 |
| Steroid diabetes | 27.21 | 26.76 | 10 | 5217 | 5244 | 110578828 |
| Blood immunoglobulin G decreased | 26.95 | 26.76 | 10 | 5217 | 5390 | 110578682 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01DC03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS CYTOTOXIC ANTIBIOTICS AND RELATED SUBSTANCES Other cytotoxic antibiotics |
| FDA MoA | N0000000236 | Alkylating Activity |
| FDA EPC | N0000175558 | Alkylating Drug |
| MeSH PA | D000477 | Alkylating Agents |
| MeSH PA | D000903 | Antibiotics, Antineoplastic |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D003432 | Cross-Linking Reagents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D007202 | Indicators and Reagents |
| MeSH PA | D019384 | Nucleic Acid Synthesis Inhibitors |
| CHEBI has role | CHEBI:24853 | intercalator |
| CHEBI has role | CHEBI:76969 | bacterial metabolite |
| CHEBI has role | CHEBI:22333 | alkylating agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01DC Other cytotoxic antibiotics 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Adenocarcinoma of pancreas | indication | 700423003 | DOID:4074 |
| Metastatic Gastric Cancer | indication | ||
| Adjunct to incisional glaucoma surgery | indication | ||
| Non-small cell lung cancer | off-label use | 254637007 | DOID:3908 |
| Malignant tumor of head and/or neck | off-label use | 255056009 | |
| Malignant tumor of anus | off-label use | 363490009 | DOID:14110 |
| Malignant tumor of urinary bladder | off-label use | 399326009 | DOID:11054 |
| Prevention of Recurrent Bladder Carcinoma | off-label use | ||
| Corneal Conjunctival Intraepithelial Neoplasm | off-label use | ||
| Stomatitis | contraindication | 61170000 | DOID:9637 |
| Acute infectious disease | contraindication | 63171007 | |
| Blood coagulation disorder | contraindication | 64779008 | DOID:1247 |
| Heart failure | contraindication | 84114007 | DOID:6000 |
| Leukopenia | contraindication | 84828003 | DOID:615 |
| Kidney disease | contraindication | 90708001 | DOID:557 |
| Hemolytic uremic syndrome | contraindication | 111407006 | DOID:12554 |
| Anemia | contraindication | 271737000 | DOID:2355 |
| Pregnancy, function | contraindication | 289908002 | |
| Thrombocytopenic disorder | contraindication | 302215000 | DOID:1588 |
| Bone marrow depression | contraindication | 307762000 | |
| Breastfeeding (mother) | contraindication | 413712001 | |
| Pulmonary Infiltrates | contraindication |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 13.54 | acidic |
| pKa2 | 10.39 | Basic |
| pKa3 | 7.53 | Basic |
| pKa4 | 4.95 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.2MG/VIAL | MITOSOL | GLAUKOS | N022572 | Feb. 7, 2012 | RX | FOR SOLUTION | TOPICAL | 9539241 | Jan. 2, 2028 | MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY |
| 0.2MG/VIAL | MITOSOL | GLAUKOS | N022572 | Feb. 7, 2012 | RX | FOR SOLUTION | TOPICAL | 9649428 | May 21, 2029 | MITOSOL IS AN ANTIMETABOLITE INDICATED AS AN ADJUNCT TO AB EXTERNO GLAUCOMA SURGERY. IT IS INTENDED FOR TOPICAL APPLICATION TO THE SITE OF GLAUCOMA FILTRATION SURGERY |
| 40MG/VIAL | JELMYTO | UROGEN PHARMA | N211728 | April 15, 2020 | RX | POWDER | PYELOCALYCEAL | 12268745 | Jan. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH LOW-GRADE UPPER TRACT UROTHELIAL CANCER |
| 40MG/VIAL | ZUSDURI | UROGEN PHARMA | N215793 | June 12, 2025 | RX | POWDER | INTRAVESICAL | 10039832 | Jan. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER |
| 40MG/VIAL | ZUSDURI | UROGEN PHARMA | N215793 | June 12, 2025 | RX | POWDER | INTRAVESICAL | 12440568 | Jan. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER |
| 40MG/VIAL | ZUSDURI | UROGEN PHARMA | N215793 | June 12, 2025 | RX | POWDER | INTRAVESICAL | 9040074 | Jan. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER |
| 40MG/VIAL | ZUSDURI | UROGEN PHARMA | N215793 | June 12, 2025 | RX | POWDER | INTRAVESICAL | 9950069 | Jan. 20, 2031 | TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 40MG/VIAL | JELMYTO | UROGEN PHARMA | N211728 | April 15, 2020 | RX | POWDER | PYELOCALYCEAL | April 15, 2027 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH LOW-GRADE UPPER TRACT UROTHELIAL CANCER (LG-UTUC) |
| 40MG/VIAL | ZUSDURI | UROGEN PHARMA | N215793 | June 12, 2025 | RX | POWDER | INTRAVESICAL | June 12, 2028 | NEW PRODUCT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Indoleamine 2,3-dioxygenase 1 | Enzyme | Ki | 4.60 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| 4018134 | VUID |
| N0000146471 | NUI |
| D00208 | KEGG_DRUG |
| 4018134 | VANDF |
| C0002475 | UMLSCUI |
| CHEBI:27504 | CHEBI |
| CHEMBL105 | ChEMBL_ID |
| D016685 | MESH_DESCRIPTOR_UI |
| DB00305 | DRUGBANK_ID |
| 3043 | INN_ID |
| 50SG953SK6 | UNII |
| 5746 | PUBCHEM_CID |
| 204298 | RXNORM |
| 1274 | MMSL |
| 140168 | MMSL |
| 1973 | MMSL |
| 5122 | MMSL |
| d00305 | MMSL |
| 002660 | NDDF |
| 387331000 | SNOMEDCT_US |
| 59240002 | SNOMEDCT_US |
| 7089 | IUPHAR_LIGAND_ID |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9135 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 17 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9136 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 17 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9279 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 17 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 0143-9280 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 17 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-108 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-115 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 16729-116 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-250 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 19 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-251 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 19 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 25021-252 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 19 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 55150-450 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 55150-451 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 55150-452 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-564 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-566 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 65219-568 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 15 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-389 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-390 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| Mitomycin | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-391 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-615 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-616 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 68001-617 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 68083-483 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 68083-484 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 15 sections |
| MITOMYCIN | Human Prescription Drug Label | 1 | 68083-502 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 15 sections |
| MUTAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-001 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 18 sections |
| MUTAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-002 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 18 sections |
| MUTAMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 69448-003 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 40 mg | INTRAVENOUS | ANDA | 18 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71288-137 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 5 mg | INTRAVENOUS | ANDA | 19 sections |
| MITOMYCIN | HUMAN PRESCRIPTION DRUG LABEL | 1 | 71288-138 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20 mg | INTRAVENOUS | ANDA | 19 sections |