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
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 1108.53 21.64 318 10562 15460 46659722
Febrile neutropenia 980.73 21.64 464 10416 94163 46581019
Myelodysplastic syndrome 367.35 21.64 138 10742 15573 46659609
Death 317.80 21.64 389 10491 335159 46340023
Thrombocytopenia 279.96 21.64 233 10647 126348 46548834
Pneumonia 261.44 21.64 375 10505 375945 46299237
Sepsis 247.42 21.64 224 10656 135790 46539392
Pancytopenia 224.89 21.64 174 10706 84884 46590298
Acute myeloid leukaemia recurrent 172.33 21.64 44 10836 1352 46673830
Myelodysplastic syndrome transformation 156.16 21.64 33 10847 428 46674754
Neutropenia 152.64 21.64 177 10703 143027 46532155
Platelet count decreased 131.33 21.64 138 10742 99886 46575296
Pyrexia 120.39 21.64 256 10624 348546 46326636
Bronchopulmonary aspergillosis 119.56 21.64 50 10830 7446 46667736
Neutrophil count decreased 110.56 21.64 87 10793 43339 46631843
Septic shock 110.14 21.64 98 10782 57795 46617387
Transformation to acute myeloid leukaemia 109.75 21.64 20 10860 111 46675071
Cytopenia 76.51 21.64 37 10843 7731 46667451
Anaemia 70.46 21.64 172 10708 255607 46419575
Blast cell count increased 68.06 21.64 16 10864 345 46674837
Differentiation syndrome 66.62 21.64 19 10861 892 46674290
Pain 66.54 21.64 15 10865 476933 46198249
Acute febrile neutrophilic dermatosis 60.55 21.64 23 10857 2662 46672520
Pneumonia fungal 60.52 21.64 26 10854 4134 46671048
White blood cell count decreased 56.52 21.64 97 10783 112134 46563048
Refractory anaemia with an excess of blasts 55.10 21.64 14 10866 421 46674761
Bone marrow failure 53.95 21.64 49 10831 29620 46645562
Respiratory failure 47.79 21.64 82 10798 94734 46580448
Organising pneumonia 47.22 21.64 23 10857 4879 46670303
Leukaemia 45.98 21.64 20 10860 3275 46671907
Infection 42.30 21.64 95 10785 133497 46541685
Headache 39.83 21.64 32 10848 478320 46196862
Cardiac failure 38.78 21.64 68 10812 79880 46595302
Cerebral haemorrhage 38.66 21.64 40 10840 28331 46646851
Arthralgia 37.71 21.64 19 10861 364584 46310598
Graft versus host disease in gastrointestinal tract 37.29 21.64 16 10864 2534 46672648
Aspergillus infection 37.21 21.64 22 10858 6868 46668314
Toxic neuropathy 37.21 21.64 10 10870 376 46674806
Cellulitis 34.36 21.64 60 10820 70228 46604954
Chloroma 33.33 21.64 8 10872 189 46674993
Pneumonitis 33.32 21.64 37 10843 28383 46646799
Acute graft versus host disease 33.18 21.64 17 10863 4013 46671169
Graft versus host disease 32.89 21.64 20 10860 6568 46668614
Myelofibrosis 32.83 21.64 12 10868 1247 46673935
Escherichia sepsis 32.38 21.64 17 10863 4221 46670961
Bacteraemia 30.96 21.64 26 10854 14153 46661029
Haemoglobin decreased 30.49 21.64 82 10798 128867 46546315
Multiple organ dysfunction syndrome 30.45 21.64 48 10832 51662 46623520
Stenotrophomonas infection 29.89 21.64 12 10868 1608 46673574
Drug hypersensitivity 29.55 21.64 10 10870 243815 46431367
Bone marrow necrosis 29.05 21.64 6 10874 69 46675113
Drug ineffective 28.95 21.64 73 10807 677765 45997417
Pulmonary sepsis 28.17 21.64 11 10869 1371 46673811
Neutropenic sepsis 27.74 21.64 23 10857 12301 46662881
Blastic plasmacytoid dendritic cell neoplasia 27.40 21.64 5 10875 28 46675154
Liver abscess 27.19 21.64 13 10867 2646 46672536
Therapy non-responder 26.76 21.64 40 10840 41112 46634070
Disease progression 26.74 21.64 63 10817 91237 46583945
Graft versus host disease in liver 26.64 21.64 8 10872 450 46674732
Acute leukaemia 26.57 21.64 10 10870 1128 46674054
Pleural effusion 26.24 21.64 59 10821 82893 46592289
Bicytopenia 26.19 21.64 11 10869 1653 46673529
Staphylococcal sepsis 25.67 21.64 18 10862 7514 46667668
Chronic myelomonocytic leukaemia 24.78 21.64 7 10873 317 46674865
Subdural haematoma 24.67 21.64 22 10858 12975 46662207
Constipation 24.02 21.64 92 10788 174005 46501177
Hypertension 23.87 21.64 8 10872 196348 46478834
General physical health deterioration 23.80 21.64 70 10810 115699 46559483
Minimal residual disease 23.79 21.64 5 10875 63 46675119
Acute erythroid leukaemia 23.67 21.64 4 10876 13 46675169
Joint swelling 23.52 21.64 5 10875 166068 46509114
Condition aggravated 23.51 21.64 14 10866 245038 46430144
Renal tubular acidosis 23.37 21.64 10 10870 1573 46673609
Nasopharyngitis 23.16 21.64 4 10876 153994 46521188
Anxiety 22.85 21.64 7 10873 181950 46493232
Full blood count decreased 22.80 21.64 27 10853 22184 46652998
Abdominal discomfort 22.57 21.64 4 10876 151161 46524021
Peripheral swelling 21.90 21.64 5 10875 158066 46517116

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 1372.47 18.28 484 17521 17522 29916951
Febrile neutropenia 1303.47 18.28 802 17203 105891 29828582
Myelodysplastic syndrome 590.78 18.28 267 17738 18511 29915962
Pneumonia 448.60 18.28 751 17254 333555 29600918
Sepsis 418.05 18.28 475 17530 145920 29788553
Platelet count decreased 266.57 18.28 323 17682 105806 29828667
Death 263.25 18.28 626 17379 356657 29577816
Neutrophil count decreased 231.96 18.28 197 17808 42257 29892216
Blast cell count increased 195.96 18.28 56 17949 993 29933480
Myelodysplastic syndrome transformation 194.18 18.28 46 17959 370 29934103
Chronic myelomonocytic leukaemia 178.15 18.28 47 17958 609 29933864
Pancytopenia 167.89 18.28 230 17775 84822 29849651
White blood cell count decreased 161.16 18.28 224 17781 83723 29850750
Septic shock 158.36 18.28 193 17812 63414 29871059
Neutropenia 156.33 18.28 278 17727 128262 29806211
Thrombocytopenia 147.28 18.28 281 17724 136763 29797710
Transformation to acute myeloid leukaemia 141.20 18.28 39 17966 607 29933866
Anaemia 126.46 18.28 340 17665 207652 29726821
Acute myeloid leukaemia recurrent 115.08 18.28 41 17964 1511 29932962
Pneumonia fungal 111.21 18.28 58 17947 5475 29928998
Infection 98.76 18.28 172 17833 77902 29856571
Pyrexia 91.59 18.28 384 17621 294105 29640368
Acute febrile neutrophilic dermatosis 80.17 18.28 29 17976 1117 29933356
Cytopenia 72.84 18.28 51 17954 8205 29926268
Tumour lysis syndrome 70.66 18.28 60 17945 12825 29921648
Drug interaction 68.11 18.28 18 17987 199550 29734923
Graft versus host disease in gastrointestinal tract 64.05 18.28 33 17972 3036 29931437
Organising pneumonia 63.47 18.28 39 17966 5035 29929438
Pyoderma gangrenosum 59.94 18.28 23 17982 1046 29933427
Blood product transfusion dependent 57.83 18.28 17 17988 334 29934139
Injection site reaction 50.75 18.28 46 17959 10714 29923759
Neutropenic sepsis 50.36 18.28 47 17958 11362 29923111
Bronchopulmonary aspergillosis 49.28 18.28 48 17957 12236 29922237
Headache 47.84 18.28 25 17980 182281 29752192
Completed suicide 45.07 18.28 4 18001 99488 29834985
Acute leukaemia 44.84 18.28 19 17986 1120 29933353
Disseminated intravascular coagulation 43.66 18.28 60 17945 22111 29912362
Bacteraemia 43.21 18.28 50 17955 15510 29918963
Myelofibrosis 42.01 18.28 20 17985 1551 29932922
Febrile bone marrow aplasia 40.93 18.28 36 17969 8061 29926412
Cardiac failure 40.40 18.28 126 17879 83292 29851181
Therapy non-responder 39.94 18.28 67 17938 29386 29905087
Necrotising fasciitis 39.33 18.28 25 17980 3424 29931049
Product dose omission issue 38.15 18.28 5 18000 91626 29842847
Graft versus host disease in skin 37.79 18.28 24 17981 3283 29931190
Cerebral haemorrhage 37.09 18.28 69 17936 32818 29901655
Enteritis infectious 36.64 18.28 17 17988 1244 29933229
Myositis 35.14 18.28 37 17968 10340 29924133
Toxicity to various agents 34.99 18.28 33 17972 177150 29757323
Cellulitis 31.83 18.28 80 17925 46704 29887769
Anxiety 30.80 18.28 8 17997 89863 29844610
Leukaemia 30.56 18.28 21 17984 3276 29931197
Meningeal neoplasm 29.04 18.28 7 17998 61 29934412
Drug hypersensitivity 27.90 18.28 4 18001 68515 29865958
Neutropenic colitis 27.53 18.28 17 17988 2213 29932260
Blood pressure increased 27.49 18.28 5 18000 71923 29862550
Somnolence 27.29 18.28 12 17993 96751 29837722
Tremor 27.22 18.28 6 17999 75357 29859116
Aeromonas infection 26.77 18.28 9 17996 278 29934195
Anal abscess 26.55 18.28 23 17982 5046 29929427
Constipation 26.53 18.28 136 17869 112770 29821703
Pain in extremity 26.20 18.28 17 17988 110204 29824269
Overdose 26.19 18.28 9 17996 84328 29850145
General physical health deterioration 26.05 18.28 124 17881 99820 29834653
Muscle spasms 25.90 18.28 4 18001 64834 29869639
Haemoglobin decreased 25.13 18.28 135 17870 113963 29820510
Arthralgia 24.84 18.28 27 17978 135764 29798709
Leukaemia recurrent 24.78 18.28 14 17991 1547 29932926
Haemoglobin abnormal 24.54 18.28 18 17987 3111 29931362
Iron overload 24.52 18.28 13 17992 1268 29933205
Neutropenic infection 24.19 18.28 12 17993 1018 29933455
Myalgia 24.12 18.28 8 17997 76659 29857814
Colitis ischaemic 23.94 18.28 23 17982 5763 29928710
Refractory anaemia with an excess of blasts 23.93 18.28 9 17996 387 29934086
Graft versus host disease 23.90 18.28 30 17975 10120 29924353
Bone marrow failure 23.55 18.28 54 17951 29731 29904742
Juvenile chronic myelomonocytic leukaemia 23.43 18.28 4 18001 3 29934470
Neutrophilic panniculitis 23.31 18.28 5 18000 24 29934449
Chloroma 22.89 18.28 9 17996 437 29934036
Leukocytosis 22.85 18.28 44 17961 21458 29913015
Urticaria 22.67 18.28 3 18002 54603 29879870
Aspergillus infection 22.18 18.28 29 17976 10185 29924288
Dizziness 21.45 18.28 54 17951 194855 29739618
Pericarditis 21.17 18.28 26 17979 8580 29925893
Epistaxis 20.29 18.28 74 17931 52907 29881566
Paraesthesia 20.28 18.28 4 18001 54323 29880150
Central nervous system leukaemia 19.67 18.28 7 17998 257 29934216
Muscular weakness 19.40 18.28 7 17998 63638 29870835
Rhabdomyolysis 19.36 18.28 7 17998 63573 29870900
Anal fissure 19.31 18.28 14 17991 2377 29932096
Injection site vasculitis 19.25 18.28 3 18002 0 29934473
Drug ineffective 19.20 18.28 123 17882 340264 29594209
Subdural haematoma 19.16 18.28 38 17967 18934 29915539
International normalised ratio increased 18.94 18.28 3 18002 47736 29886737
Thrombocytosis 18.92 18.28 16 17989 3397 29931076
Pain 18.85 18.28 48 17957 172593 29761880
Insomnia 18.85 18.28 17 17988 93319 29841154
Seizure 18.65 18.28 19 17986 98456 29836017
Condition aggravated 18.65 18.28 34 17971 137832 29796641
Sinusitis aspergillus 18.59 18.28 5 18000 70 29934403
Weight increased 18.56 18.28 11 17994 74902 29859571
Acute myeloid leukaemia refractory 18.52 18.28 4 18001 20 29934453

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)

None

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 DRUGBANK CHEMBL
DNA (cytosine-5)-methyltransferase 3A Enzyme INHIBITOR CHEMBL CHEMBL

External reference:

IDSource
M801H13NRU UNII
4021468 VUID
N0000148852 NUI
D03021 KEGG_DRUG
C0004475 UMLSCUI
CHEBI:2038 CHEBI
5AE PDB_CHEM_ID
CHEMBL1489 ChEMBL_ID
9444 PUBCHEM_CID
DB00928 DRUGBANK_ID
D001374 MESH_DESCRIPTOR_UI
4520 INN_ID
6796 IUPHAR_LIGAND_ID
1251 RXNORM
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 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 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