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

Stem definitionDrug idCAS RN
nucleosides antiviral or antineoplastic agents, cytarabine or azacitidine derivatives 25 320-67-2

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • 5-azacytidine
  • azacitidine
  • azacytidine
  • ladakamycin
  • ledakamycin
  • vidaza
  • U-18496
A pyrimidine analogue that inhibits DNA methyltransferase, impairing DNA methylation. It is also an antimetabolite of cytidine, incorporated primarily into RNA. Azacytidine has been used as an antineoplastic agent.
  • Molecular weight: 244.21
  • Formula: C8H12N4O5
  • CLOGP: -2.20
  • LIPINSKI: 0
  • HAC: 9
  • HDO: 4
  • TPSA: 140.97
  • ALOGS: -1.30
  • ROTB: 2

  • Status: OFP

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

Drug dosage:

None

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 89 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 62 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 177.10 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
Vd (Volume of distribution) 0.47 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 35 mL/min/kg Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.36 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Jan. 21, 2011 PMDA Nippon Shinyaku Co., Ltd.
Aug. 2, 2019 EMA Celgene Europe BV
May 19, 2004 FDA CELGENE

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
Acute myeloid leukaemia 1253.23 22.05 357 12324 16575 53319810
Febrile neutropenia 1193.59 22.05 552 12129 104384 53232001
Myelodysplastic syndrome 367.43 22.05 141 12540 16519 53319866
Thrombocytopenia 352.18 22.05 279 12402 138448 53197937
Death 335.97 22.05 417 12264 356815 52979570
Pneumonia 307.95 22.05 427 12254 406742 52929643
Sepsis 277.58 22.05 249 12432 146180 53190205
Neutropenia 235.40 22.05 236 12445 158949 53177436
Pancytopenia 228.42 22.05 182 12499 90746 53245639
Acute myeloid leukaemia recurrent 222.13 22.05 55 12626 1458 53334927
Myelodysplastic syndrome transformation 155.86 22.05 33 12648 423 53335962
Platelet count decreased 139.19 22.05 149 12532 107950 53228435
Septic shock 131.94 22.05 113 12568 62116 53274269
Bronchopulmonary aspergillosis 131.13 22.05 56 12625 8609 53327776
Neutrophil count decreased 124.64 22.05 99 12582 48999 53287386
Pyrexia 121.76 22.05 284 12397 402909 52933476
Transformation to acute myeloid leukaemia 115.52 22.05 22 12659 157 53336228
Blast cell count increased 101.54 22.05 23 12658 410 53335975
Anaemia 100.38 22.05 210 12471 276508 53059877
Cytopenia 96.53 22.05 46 12635 9124 53327261
Pain 85.55 22.05 18 12663 588380 52748005
Differentiation syndrome 76.62 22.05 22 12659 1037 53335348
Pneumonia fungal 73.45 22.05 31 12650 4625 53331760
White blood cell count decreased 65.61 22.05 111 12570 124364 53212021
Acute febrile neutrophilic dermatosis 61.91 22.05 24 12657 2877 53333508
Myelosuppression 58.45 22.05 37 12644 12791 53323594
Refractory anaemia with an excess of blasts 54.57 22.05 14 12667 429 53335956
Respiratory failure 53.43 22.05 90 12591 100422 53235963
Arthralgia 53.43 22.05 19 12662 439764 52896621
Bone marrow failure 52.48 22.05 49 12632 30066 53306319
Aspergillus infection 50.94 22.05 28 12653 7468 53328917
Leukaemia 49.69 22.05 22 12659 3684 53332701
Organising pneumonia 48.46 22.05 24 12657 5172 53331213
Cerebral haemorrhage 45.09 22.05 45 12636 29951 53306434
Headache 42.69 22.05 39 12642 536782 52799603
Multiple organ dysfunction syndrome 41.02 22.05 58 12623 55619 53280766
Infection 39.86 22.05 110 12571 172095 53164290
Cardiac failure 39.29 22.05 72 12609 85772 53250613
Graft versus host disease 38.72 22.05 23 12658 7099 53329286
Graft versus host disease in gastrointestinal tract 37.78 22.05 17 12664 2957 53333428
Acute graft versus host disease 37.49 22.05 19 12662 4298 53332087
Toxic neuropathy 36.58 22.05 10 12671 393 53335992
Escherichia sepsis 36.43 22.05 19 12662 4562 53331823
Abdominal discomfort 35.87 22.05 5 12676 221057 53115328
Myelofibrosis 35.79 22.05 13 12668 1301 53335084
Drug hypersensitivity 34.75 22.05 10 12671 265232 53071153
Bacteraemia 34.46 22.05 29 12652 15520 53320865
Swelling 34.34 22.05 3 12678 191102 53145283
Joint swelling 34.34 22.05 7 12674 234631 53101754
Alopecia 34.33 22.05 7 12674 234576 53101809
Disease progression 34.08 22.05 75 12606 101845 53234540
Graft versus host disease in skin 33.18 22.05 15 12666 2638 53333747
Peripheral swelling 32.66 22.05 5 12676 206103 53130282
Cellulitis 32.60 22.05 62 12619 75927 53260458
Condition aggravated 32.51 22.05 15 12666 297119 53039266
Nasopharyngitis 32.03 22.05 4 12677 192291 53144094
Chloroma 31.98 22.05 8 12673 221 53336164
Pulmonary sepsis 30.60 22.05 12 12669 1483 53334902
Haemoglobin decreased 30.07 22.05 86 12595 137221 53199164
Soft tissue infection 29.88 22.05 13 12668 2088 53334297
Iron overload 29.83 22.05 10 12671 789 53335596
Graft versus host disease in liver 29.72 22.05 9 12672 511 53335874
Subdural haematoma 29.05 22.05 25 12656 13788 53322597
Liver abscess 28.97 22.05 14 12667 2861 53333524
Stenotrophomonas infection 28.86 22.05 12 12669 1724 53334661
Bone marrow necrosis 28.77 22.05 6 12675 71 53336314
Pneumonitis 28.61 22.05 36 12645 30852 53305533
Hypertension 28.61 22.05 9 12672 225422 53110963
Pleural effusion 28.28 22.05 64 12617 88515 53247870
Acute erythroid leukaemia 27.77 22.05 5 12676 25 53336360
Blastic plasmacytoid dendritic cell neoplasia 27.30 22.05 5 12676 28 53336357
Acute myeloid leukaemia refractory 27.15 22.05 5 12676 29 53336356
Minimal residual disease 26.64 22.05 6 12675 104 53336281
Maternal exposure during pregnancy 26.50 22.05 3 12678 155636 53180749
Acute leukaemia 26.06 22.05 10 12671 1166 53335219
Neutropenic sepsis 25.83 22.05 24 12657 14625 53321760
Hypersensitivity 25.70 22.05 9 12672 210656 53125729
Renal tubular acidosis 25.44 22.05 11 12670 1740 53334645
Staphylococcal sepsis 24.70 22.05 18 12663 7822 53328563
Anxiety 24.69 22.05 8 12673 196696 53139689
Weight increased 24.51 22.05 9 12672 204558 53131827
Chronic myelomonocytic leukaemia 24.29 22.05 7 12674 334 53336051
Constipation 23.96 22.05 102 12579 198310 53138075
Drug ineffective 23.75 22.05 107 12574 817138 52519247
Bicytopenia 23.52 22.05 11 12670 2090 53334295
Therapy non-responder 23.48 22.05 42 12639 49078 53287307
Renal tubular disorder 23.12 22.05 12 12669 2851 53333534
Leukopenia 22.25 22.05 52 12629 73411 53262974
General physical health deterioration 22.15 22.05 81 12600 146861 53189524
Intestinal ulcer 22.10 22.05 9 12672 1226 53335159

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
Acute myeloid leukaemia 1520.39 17.87 536 19767 18638 32474585
Febrile neutropenia 1424.62 17.87 897 19406 118669 32374554
Myelodysplastic syndrome 617.05 17.87 284 20019 19754 32473469
Pneumonia 477.53 17.87 816 19487 354436 32138787
Sepsis 420.22 17.87 505 19798 158329 32334894
Death 281.61 17.87 686 19617 381831 32111392
Platelet count decreased 280.69 17.87 351 19952 114240 32378983
Neutrophil count decreased 234.85 17.87 211 20092 46928 32446295
Blast cell count increased 204.77 17.87 59 20244 1036 32492187
Neutropenia 204.19 17.87 338 19965 141837 32351386
Myelodysplastic syndrome transformation 194.58 17.87 47 20256 397 32492826
Chronic myelomonocytic leukaemia 194.07 17.87 51 20252 624 32492599
Pancytopenia 191.18 17.87 259 20044 90976 32402247
Septic shock 182.58 17.87 220 20083 68769 32424454
White blood cell count decreased 163.02 17.87 240 20063 90958 32402265
Thrombocytopenia 158.33 17.87 310 19993 147989 32345234
Transformation to acute myeloid leukaemia 154.44 17.87 43 20260 663 32492560
Acute myeloid leukaemia recurrent 148.81 17.87 53 20250 1877 32491346
Anaemia 142.51 17.87 381 19922 223243 32269980
Tumour lysis syndrome 121.07 17.87 88 20215 14459 32478764
Infection 120.76 17.87 201 20102 84514 32408709
Pneumonia fungal 118.72 17.87 64 20239 6216 32487007
Pyrexia 111.82 17.87 444 19859 319524 32173699
Cytopenia 95.58 17.87 66 20237 9998 32483225
Acute febrile neutrophilic dermatosis 94.06 17.87 34 20269 1257 32491966
Drug interaction 74.45 17.87 22 20281 218163 32275060
Organising pneumonia 72.91 17.87 45 20258 5636 32487587
Bacteraemia 63.28 17.87 66 20237 17567 32475656
Bronchopulmonary aspergillosis 61.67 17.87 58 20245 13629 32479594
Graft versus host disease in gastrointestinal tract 59.32 17.87 33 20270 3408 32489815
Neutropenic sepsis 57.57 17.87 54 20249 12645 32480578
Blood product transfusion dependent 57.24 17.87 17 20286 333 32492890
Pyoderma gangrenosum 56.18 17.87 23 20280 1195 32492028
Headache 54.91 17.87 27 20276 196170 32297053
Injection site reaction 46.42 17.87 46 20257 11523 32481700
Product dose omission issue 46.39 17.87 5 20298 102570 32390653
Disseminated intravascular coagulation 45.68 17.87 64 20239 23112 32470111
Acute leukaemia 43.52 17.87 19 20284 1159 32492064
Cardiac failure 43.52 17.87 141 20162 91532 32401691
Completed suicide 43.16 17.87 4 20299 92513 32400710
Febrile bone marrow aplasia 42.46 17.87 38 20265 8377 32484846
Myelofibrosis 40.05 17.87 20 20283 1657 32491566
Cerebral haemorrhage 39.79 17.87 75 20228 34672 32458551
Necrotising fasciitis 38.82 17.87 26 20277 3743 32489480
Toxicity to various agents 38.25 17.87 33 20270 178008 32315215
Therapy non-responder 38.03 17.87 71 20232 32583 32460640
Graft versus host disease 37.96 17.87 40 20263 10766 32482457
Leukaemia 37.50 17.87 26 20277 3960 32489263
Myositis 36.67 17.87 40 20263 11195 32482028
Anxiety 35.90 17.87 8 20295 95997 32397226
Graft versus host disease in skin 35.07 17.87 24 20279 3580 32489643
Soft tissue infection 34.52 17.87 19 20284 1921 32491302
Enteritis infectious 34.18 17.87 17 20286 1396 32491827
Cellulitis 33.20 17.87 87 20216 50143 32443080
Blood pressure increased 33.13 17.87 5 20298 79349 32413874
Somnolence 32.65 17.87 12 20291 103785 32389438
Tremor 31.99 17.87 6 20297 81271 32411952
Muscle spasms 30.42 17.87 4 20299 70414 32422809
Drug hypersensitivity 29.80 17.87 5 20298 73395 32419828
Aeromonas infection 29.49 17.87 10 20293 305 32492918
Overdose 29.24 17.87 9 20294 87068 32406155
Arthralgia 28.95 17.87 30 20273 148418 32344805
Meningeal neoplasm 28.78 17.87 7 20296 61 32493162
Anal abscess 27.72 17.87 25 20278 5565 32487658
Bone marrow failure 26.92 17.87 59 20244 30345 32462878
Refractory anaemia with an excess of blasts 26.51 17.87 10 20293 417 32492806
Leukaemia recurrent 26.30 17.87 15 20288 1624 32491599
Myalgia 26.20 17.87 9 20294 81221 32412002
General physical health deterioration 25.91 17.87 141 20162 115118 32378105
Aspergillus infection 25.89 17.87 34 20269 11540 32481683
Dyspnoea 25.50 17.87 128 20175 361917 32131306
Haemoglobin abnormal 24.75 17.87 19 20284 3386 32489837
Constipation 24.74 17.87 149 20154 126224 32366999
Pain 24.67 17.87 50 20253 187506 32305717
Haemoglobin decreased 24.65 17.87 143 20160 119528 32373695
Neutropenic colitis 24.64 17.87 17 20286 2568 32490655
Pain in extremity 24.36 17.87 23 20280 118878 32374345
Weight increased 24.15 17.87 11 20292 83652 32409571
Epistaxis 23.89 17.87 83 20220 55772 32437451
Iron overload 23.64 17.87 13 20290 1312 32491911
Dizziness 23.44 17.87 61 20242 209557 32283666
Juvenile chronic myelomonocytic leukaemia 23.28 17.87 4 20299 3 32493220
Neutrophilic panniculitis 23.12 17.87 5 20298 24 32493199
Condition aggravated 22.67 17.87 39 20264 155622 32337601
Leukocytosis 22.46 17.87 47 20256 23420 32469803
Urticaria 22.21 17.87 5 20298 59609 32433614
Hypoaesthesia 21.53 17.87 5 20298 58348 32434875
Subdural haematoma 21.52 17.87 42 20261 19911 32473312
Colitis ischaemic 21.50 17.87 23 20280 6297 32486926
Drug ineffective 21.44 17.87 146 20157 383331 32109892
Minimal residual disease 21.41 17.87 8 20295 325 32492898
Acute graft versus host disease 21.35 17.87 23 20280 6347 32486876
Chest discomfort 21.35 17.87 3 20300 50227 32442996
Chloroma 21.34 17.87 9 20294 504 32492719
Peripheral swelling 21.31 17.87 8 20295 68337 32424886
Neutropenic infection 21.29 17.87 12 20291 1270 32491953
Myelosuppression 21.17 17.87 31 20272 11645 32481578
Hyperhidrosis 21.10 17.87 9 20294 71159 32422064
Insomnia 21.04 17.87 19 20284 100329 32392894
Depression 20.80 17.87 18 20285 97042 32396181
International normalised ratio increased 20.67 17.87 3 20300 49032 32444191
Pneumonia mycoplasmal 20.28 17.87 9 20294 571 32492652
Seizure 20.22 17.87 21 20282 103833 32389390
Pulmonary sepsis 20.03 17.87 14 20289 2160 32491063
Paraesthesia 19.95 17.87 6 20297 58938 32434285
Full blood count decreased 19.82 17.87 37 20266 16973 32476250
Escherichia bacteraemia 19.34 17.87 16 20287 3173 32490050
Red blood cell count decreased 19.22 17.87 49 20254 27764 32465459
Injection site vasculitis 19.14 17.87 3 20300 0 32493223
Differentiation syndrome 18.86 17.87 11 20292 1242 32491981
Multiple organ dysfunction syndrome 18.86 17.87 90 20213 69764 32423459
Escherichia sepsis 18.77 17.87 18 20285 4330 32488893
Malaise 18.70 17.87 53 20250 177085 32316138
Pericarditis 18.63 17.87 26 20277 9347 32483876
Acute graft versus host disease in skin 18.58 17.87 19 20284 4938 32488285
Central nervous system leukaemia 18.53 17.87 7 20296 293 32492930
Weight decreased 18.38 17.87 48 20255 164770 32328453
Gait disturbance 18.36 17.87 14 20289 80394 32412829
Disease progression 18.00 17.87 104 20199 86758 32406465
Muscular weakness 17.99 17.87 10 20293 67919 32425304

Pharmacologic Action:

SourceCodeDescription
ATC L01BC07 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
ANTIMETABOLITES
Pyrimidine analogues
FDA MoA N0000000233 Nucleic Acid Synthesis Inhibitors
FDA EPC N0000175595 Nucleoside Metabolic Inhibitor
CHEBI has role CHEBI:35610 cytostatic
MeSH PA D000963 Antimetabolites
MeSH PA D000964 Antimetabolites, Antineoplastic
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D009676 Noxae

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Acute myeloid leukemia, disease indication 91861009
Myelodysplastic syndrome indication 109995007
Chronic myelomonocytic leukemia indication 127225006
Hepatic failure contraindication 59927004
Kidney disease contraindication 90708001 DOID:557
Pregnancy, function contraindication 289908002
Thrombocytopenic disorder contraindication 302215000 DOID:1588
Neutropenic disorder contraindication 303011007 DOID:1227
Breastfeeding (mother) contraindication 413712001
Advanced Malignant Neoplasm of Liver contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 12.32 acidic
pKa2 12.92 acidic
pKa3 13.79 acidic
pKa4 4.43 Basic
pKa5 2.98 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
200MG ONUREG CELGENE CORP N214120 Sept. 1, 2020 RX TABLET ORAL 8846628 June 3, 2030 CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
300MG ONUREG CELGENE CORP N214120 Sept. 1, 2020 RX TABLET ORAL 8846628 June 3, 2030 CONTINUED TREATMENT OF ADULTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR CR WITH INCOMPLETE BLOOD COUNT RECOVERY FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
200MG ONUREG CELGENE CORP N214120 Sept. 1, 2020 RX TABLET ORAL Sept. 1, 2023 NEW PRODUCT
300MG ONUREG CELGENE CORP N214120 Sept. 1, 2020 RX TABLET ORAL Sept. 1, 2023 NEW PRODUCT
200MG ONUREG CELGENE CORP N214120 Sept. 1, 2020 RX TABLET ORAL Sept. 1, 2027 INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY
300MG ONUREG CELGENE CORP N214120 Sept. 1, 2020 RX TABLET ORAL Sept. 1, 2027 INDICATED FOR CONTINUED TREATMENT OF ADULT PATIENTS WITH ACUTE MYELOID LEUKEMIA WHO ACHIEVED FIRST COMPLETE REMISSION (CR) OR COMPLETE REMISSION WITH INCOMPLETE BLOOD COUNT RECOVERY (CRI) FOLLOWING INTENSIVE INDUCTION CHEMOTHERAPY AND ARE NOT ABLE TO COMPLETE INTENSIVE CURATIVE THERAPY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
DNA (cytosine-5)-methyltransferase 1 Enzyme INHIBITOR IC50 6.52 CHEMBL CHEMBL
DNA (cytosine-5)-methyltransferase 3A Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
4021468 VUID
N0000148852 NUI
D03021 KEGG_DRUG
1251 RXNORM
C0004475 UMLSCUI
CHEBI:2038 CHEBI
5AE PDB_CHEM_ID
CHEMBL1489 ChEMBL_ID
D001374 MESH_DESCRIPTOR_UI
DB00928 DRUGBANK_ID
6796 IUPHAR_LIGAND_ID
4520 INN_ID
M801H13NRU UNII
9444 PUBCHEM_CID
18639 MMSL
205981 MMSL
53994 MMSL
d05293 MMSL
008661 NDDF
412328000 SNOMEDCT_US
412329008 SNOMEDCT_US
88551000 SNOMEDCT_US
4021468 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 0143-9606 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 0781-3253 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS NDA AUTHORIZED GENERIC 26 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 0781-9253 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS NDA AUTHORIZED GENERIC 26 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 16714-927 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 24 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 16729-306 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 43598-305 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 24 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 43598-465 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 24 sections
AZACITIDINE AZACITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 43598-678 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 43817-906 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 28 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 51991-797 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 28 sections
VIDAZA HUMAN PRESCRIPTION DRUG LABEL 1 59572-102 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 25 sections
ONUREG HUMAN PRESCRIPTION DRUG LABEL 1 59572-730 TABLET, FILM COATED 200 mg ORAL NDA 31 sections
ONUREG HUMAN PRESCRIPTION DRUG LABEL 1 59572-740 TABLET, FILM COATED 300 mg ORAL NDA 31 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 63323-771 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
AZACITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 64679-096 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 67457-254 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 27 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 68001-313 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS NDA 17 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 68001-504 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 26 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 68001-527 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 69097-368 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
azacitidine for HUMAN PRESCRIPTION DRUG LABEL 1 69097-805 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 24 sections
AZACITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 70121-1237 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 25 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 71288-115 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 25 sections
Azacitidine HUMAN PRESCRIPTION DRUG LABEL 1 71288-153 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg SUBCUTANEOUS ANDA 25 sections
AZACITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 72485-201 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 23 sections
AZACITIDINE HUMAN PRESCRIPTION DRUG LABEL 1 72606-558 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION 100 mg INTRAVENOUS ANDA 24 sections