bicalutamide ๐Ÿถ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
non-steroid antiandrogens 367 90357-06-5

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ICI 176334
  • ICI-176334
  • bicalutamide
  • casodex
Bicalutamide is a non-steroidal androgen receptor inhibitor. It competitively inhibits the action of androgens by binding to cytosol androgen receptors in the target tissue. Prostatic carcinoma is known to be androgen sensitive and responds to treatment that counteracts the effect of androgen and/or removes the source of androgen.
  • Molecular weight: 430.37
  • Formula: C18H14F4N2O4S
  • CLOGP: 2.71
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 107.26
  • ALOGS: -4.67
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
50 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 2 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 0.01 mg/mL Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 1.94 ยตM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD

Approvals:

DateAgencyCompanyOrphan
Oct. 4, 1995 FDA ASTRAZENECA

FDA Adverse Event Reporting System (Female)

None

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
Prostatic specific antigen increased 878.16 12.92 341 22964 12223 29538999
Prostate cancer 363.76 12.92 235 23070 25292 29525930
Prostate cancer metastatic 319.18 12.92 127 23178 4839 29546383
Osteonecrosis of jaw 311.79 12.92 182 23123 16328 29534894
Metastases to bone 304.68 12.92 151 23154 9747 29541475
Interstitial lung disease 250.33 12.92 266 23039 57452 29493770
Malignant neoplasm progression 222.28 12.92 282 23023 73577 29477645
Hot flush 219.35 12.92 140 23165 14730 29536492
Hormone-refractory prostate cancer 118.80 12.92 36 23269 593 29550629
Osteonecrosis 106.48 12.92 87 23218 13432 29537790
Prostate cancer recurrent 90.11 12.92 32 23273 883 29550339
Bone lesion 79.46 12.92 40 23265 2664 29548558
Torsade de pointes 74.85 12.92 53 23252 6608 29544614
Toxicity to various agents 71.34 12.92 24 23281 173637 29377585
Blood testosterone increased 66.01 12.92 26 23279 962 29550260
Tooth extraction 61.15 12.92 39 23266 4090 29547132
Bone disorder 60.36 12.92 44 23261 5739 29545483
Gynaecomastia 58.72 12.92 50 23255 8167 29543055
Metastasis 54.82 12.92 34 23271 3395 29547827
Haematuria 53.88 12.92 112 23193 44027 29507195
Hepatic function abnormal 51.94 12.92 103 23202 39156 29512066
Breast cancer male 51.84 12.92 16 23289 281 29550941
Hypocalcaemia 51.38 12.92 72 23233 20593 29530629
Drug abuse 50.90 12.92 3 23302 79880 29471342
Metastases to lymph nodes 49.90 12.92 34 23271 3983 29547239
Metastases to spine 46.42 12.92 26 23279 2150 29549072
Completed suicide 45.72 12.92 8 23297 90238 29460984
Exposed bone in jaw 43.71 12.92 22 23283 1464 29549758
Hydronephrosis 42.71 12.92 43 23262 8687 29542535
Prostatic specific antigen abnormal 42.20 12.92 15 23290 415 29550807
Bone pain 39.63 12.92 60 23245 18392 29532830
Blood testosterone abnormal 38.83 12.92 13 23292 299 29550923
Pain in jaw 37.37 12.92 46 23259 11595 29539627
Disease progression 36.23 12.92 144 23161 81772 29469450
Injection site induration 34.87 12.92 23 23282 2553 29548669
Breast tenderness 34.69 12.92 15 23290 705 29550517
Osteomyelitis 34.42 12.92 48 23257 13661 29537561
Anti-androgen withdrawal syndrome 33.25 12.92 6 23299 5 29551217
Cardiac failure 33.16 12.92 137 23168 79150 29472072
Pituitary haemorrhage 32.12 12.92 10 23295 181 29551041
Metastases to lung 31.84 12.92 35 23270 7820 29543402
Electrocardiogram QT prolonged 30.14 12.92 79 23226 36058 29515164
Urinary retention 30.02 12.92 73 23232 31825 29519397
Breast swelling 29.99 12.92 10 23295 227 29550995
Spinal cord compression 28.08 12.92 23 23282 3559 29547663
Anaemia 28.00 12.92 261 23044 200690 29350532
Retroperitoneal lymphadenopathy 27.66 12.92 13 23292 744 29550478
Urinary tract obstruction 27.60 12.92 22 23283 3275 29547947
Sequestrectomy 26.33 12.92 9 23296 221 29551001
Cystitis radiation 26.30 12.92 7 23298 70 29551152
Metastases to liver 26.09 12.92 39 23266 11817 29539405
Metastases to soft tissue 25.95 12.92 9 23296 231 29550991
Injection site abscess 25.37 12.92 12 23293 697 29550525
Blood alkaline phosphatase increased 23.58 12.92 62 23243 28344 29522878
Cholangitis sclerosing 23.44 12.92 13 23292 1054 29550168
Gingivitis 23.29 12.92 19 23286 2923 29548299
Product monitoring error 22.90 12.92 18 23287 2627 29548595
Osteosclerosis 22.77 12.92 13 23292 1115 29550107
Intercepted product preparation error 22.76 12.92 17 23288 2300 29548922
Abscess jaw 22.75 12.92 11 23294 671 29550551
Bone sequestrum 22.49 12.92 10 23295 503 29550719
Phyllodes tumour 22.35 12.92 4 23301 3 29551219
Osteitis 22.06 12.92 14 23291 1455 29549767
Cerebral infarction 21.66 12.92 55 23250 24620 29526602
Metastases to eye 21.25 12.92 6 23299 76 29551146
Radiation proctitis 21.25 12.92 6 23299 76 29551146
Loss of libido 20.69 12.92 16 23289 2280 29548942
Metastases to breast 20.55 12.92 4 23301 7 29551215
Central nervous system mass 20.51 12.92 6 23299 87 29551135
Muscular weakness 20.50 12.92 100 23205 61952 29489270
Radiation injury 20.35 12.92 9 23296 447 29550775
Wall motion score index abnormal 19.90 12.92 6 23299 97 29551125
Dysuria 19.68 12.92 50 23255 22390 29528832
Back pain 19.67 12.92 143 23162 102141 29449081
Bone debridement 19.65 12.92 7 23298 195 29551027
Toothache 19.29 12.92 23 23282 5609 29545613
Testicular atrophy 19.27 12.92 9 23296 508 29550714
Conjunctival ulcer 19.26 12.92 5 23300 45 29551177
Hyperadrenalism 19.26 12.92 5 23300 45 29551177
Bone swelling 19.25 12.92 7 23298 207 29551015
Purulent discharge 19.21 12.92 16 23289 2534 29548688
Pneumonia 19.16 12.92 161 23144 320011 29231211
Anaesthesia 18.88 12.92 5 23300 49 29551173
Radical prostatectomy 18.70 12.92 5 23300 51 29551171
Breast pain 18.67 12.92 12 23293 1275 29549947
Neuroendocrine carcinoma 18.64 12.92 8 23297 369 29550853
Atopy 18.57 12.92 6 23299 123 29551099
Bone trimming 18.44 12.92 3 23302 0 29551222
Androgens increased 18.44 12.92 3 23302 0 29551222
Jaw disorder 18.10 12.92 14 23291 1996 29549226
Airway remodelling 17.80 12.92 6 23299 141 29551081
Gingival swelling 17.48 12.92 11 23294 1126 29550096
Fatigue 17.11 12.92 347 22958 316474 29234748
Disseminated intravascular coagulation 16.98 12.92 44 23261 19936 29531286
Sepsis 16.78 12.92 57 23248 142625 29408597
COVID-19 16.56 12.92 4 23301 36010 29515212
Decreased appetite 16.46 12.92 181 23124 145161 29406061
Infusion related reaction 16.42 12.92 7 23298 43879 29507343
Ureteric rupture 16.36 12.92 3 23302 3 29551219
BRCA2 gene mutation 16.36 12.92 3 23302 3 29551219
Drug hypersensitivity 16.19 12.92 18 23287 68388 29482834
Abdominal wall haematoma 16.12 12.92 12 23293 1615 29549607
Asthenia 15.96 12.92 248 23057 215002 29336220
Off label use 15.91 12.92 156 23149 300644 29250578
Breakthrough pain 15.79 12.92 8 23297 540 29550682
Headache 15.77 12.92 77 23228 173930 29377292
Dental care 15.74 12.92 6 23299 203 29551019
Oral surgery 15.66 12.92 8 23297 549 29550673
Prostatic specific antigen decreased 15.64 12.92 5 23300 99 29551123
Pelvic pain 15.57 12.92 13 23292 2066 29549156
Debridement 15.35 12.92 9 23296 811 29550411
Coccydynia 15.15 12.92 7 23298 385 29550837
Polyneuropathy in malignant disease 15.06 12.92 5 23300 112 29551110
Neuroendocrine carcinoma metastatic 14.94 12.92 5 23300 115 29551107
Oral infection 14.93 12.92 12 23293 1808 29549414
Overdose 14.86 12.92 25 23280 79794 29471428
Cardiac septal defect 14.72 12.92 6 23299 243 29550979
Injection site ulcer 14.70 12.92 6 23299 244 29550978
Cough 14.64 12.92 51 23254 126676 29424546
Eye colour change 14.49 12.92 6 23299 253 29550969
Ectopic ACTH syndrome 14.29 12.92 3 23302 9 29551213
Orchidectomy 14.22 12.92 4 23301 50 29551172
Respiratory symptom 14.17 12.92 9 23296 937 29550285
Rheumatoid arthritis 13.96 12.92 4 23301 32148 29519074
Rash 13.93 12.92 90 23215 189729 29361493
Product dose omission issue 13.87 12.92 35 23270 96348 29454874
Urinary tract infection 13.81 12.92 101 23204 72253 29478969
Penile oedema 13.76 12.92 6 23299 288 29550934
Bone cancer metastatic 13.75 12.92 5 23300 148 29551074
Pathological fracture 13.63 12.92 16 23289 3839 29547383
Prescribed underdose 13.53 12.92 23 23282 7763 29543459
Metastases to spinal cord 13.43 12.92 3 23302 13 29551209
Vipoma 13.25 12.92 3 23302 14 29551208
Poor peripheral circulation 13.19 12.92 10 23295 1384 29549838
Gingival abscess 13.09 12.92 5 23300 170 29551052
Product name confusion 13.08 12.92 4 23301 68 29551154
Febrile neutropenia 13.08 12.92 45 23260 112195 29439027

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
Prostatic specific antigen increased 943.62 13.56 259 18405 8501 64471567
Prostate cancer 474.94 13.56 188 18476 19607 64460461
Prostate cancer metastatic 270.85 13.56 79 18585 3225 64476843
Interstitial lung disease 264.72 13.56 222 18442 97510 64382558
Osteonecrosis of jaw 259.92 13.56 155 18509 39670 64440398
Metastases to bone 209.02 13.56 107 18557 20328 64459740
Malignant neoplasm progression 179.66 13.56 191 18473 112680 64367388
Hot flush 127.00 13.56 106 18558 46129 64433939
Hormone-refractory prostate cancer 111.32 13.56 25 18639 347 64479721
Prostate cancer recurrent 103.65 13.56 27 18637 718 64479350
Blood testosterone increased 78.82 13.56 22 18642 764 64479304
Gynaecomastia 77.87 13.56 37 18627 5979 64474089
Torsade de pointes 76.95 13.56 53 18611 17310 64462758
Haematuria 75.03 13.56 90 18574 60381 64419687
Hepatic function abnormal 69.02 13.56 89 18575 64224 64415844
Osteonecrosis 60.03 13.56 56 18608 28173 64451895
Metastasis 55.83 13.56 29 18635 5666 64474402
Disease progression 55.54 13.56 125 18539 141555 64338513
Urinary retention 52.64 13.56 68 18596 49133 64430935
Hypocalcaemia 51.54 13.56 62 18602 41691 64438377
Cardiac failure 46.62 13.56 112 18552 132261 64347807
Toxicity to various agents 45.90 13.56 24 18640 363489 64116579
Death 45.45 13.56 266 18398 482439 63997629
Bone lesion 44.26 13.56 24 18640 5113 64474955
Anaemia 42.54 13.56 219 18445 378461 64101607
Completed suicide 42.44 13.56 7 18657 224407 64255661
Hydronephrosis 42.14 13.56 34 18630 14091 64465977
Intercepted product preparation error 41.82 13.56 17 18647 1891 64478177
Breast cancer male 40.59 13.56 10 18654 211 64479857
Metastases to lymph nodes 39.55 13.56 27 18637 8690 64471378
Anti-androgen withdrawal syndrome 39.25 13.56 6 18658 5 64480063
Pituitary haemorrhage 37.56 13.56 10 18654 290 64479778
Erectile dysfunction 36.84 13.56 30 18634 12597 64467471
Rheumatoid arthritis 36.31 13.56 3 18661 164291 64315777
Headache 36.26 13.56 61 18603 529406 63950662
Metastases to lung 35.81 13.56 32 18632 15232 64464836
Exposed bone in jaw 32.03 13.56 17 18647 3470 64476598
Loss of libido 31.77 13.56 15 18649 2389 64477679
Electrocardiogram QT prolonged 30.99 13.56 70 18594 79378 64400690
Prostatic specific antigen abnormal 30.81 13.56 8 18656 210 64479858
Infusion related reaction 29.21 13.56 6 18658 164461 64315607
Metastases to spine 28.58 13.56 16 18648 3627 64476441
Cholangitis sclerosing 28.55 13.56 13 18651 1906 64478162
Alopecia 27.52 13.56 7 18657 165683 64314385
Product monitoring error 27.40 13.56 18 18646 5436 64474632
Testicular atrophy 27.24 13.56 8 18656 334 64479734
Urinary tract obstruction 27.12 13.56 16 18648 4001 64476067
Drug hypersensitivity 26.75 13.56 18 18646 237797 64242271
Sinusitis 26.60 13.56 5 18659 145923 64334145
Radiation proctitis 26.53 13.56 6 18658 86 64479982
Central nervous system mass 26.22 13.56 6 18658 91 64479977
Metastases to soft tissue 26.16 13.56 8 18656 384 64479684
Wall motion score index abnormal 25.86 13.56 6 18658 97 64479971
Acute myocardial infarction 25.61 13.56 60 18604 69658 64410410
Metastases to liver 25.46 13.56 33 18631 23908 64456160
Radiation injury 24.93 13.56 9 18655 725 64479343
Cystitis radiation 24.80 13.56 6 18658 117 64479951
Hypersensitivity 24.72 13.56 13 18651 196439 64283629
Blood alkaline phosphatase increased 24.69 13.56 52 18612 56227 64423841
Asthenia 24.40 13.56 209 18455 427835 64052233
Drug interaction 23.99 13.56 183 18481 361900 64118168
Neuroendocrine carcinoma 23.99 13.56 8 18656 509 64479559
Syringe issue 23.64 13.56 15 18649 4271 64475797
Dysuria 23.47 13.56 43 18621 42014 64438054
Nasopharyngitis 23.20 13.56 14 18650 196059 64284009
Therapeutic product effect decreased 23.18 13.56 3 18661 115348 64364720
Blood testosterone abnormal 22.77 13.56 6 18658 167 64479901
Prostatic specific antigen decreased 22.71 13.56 5 18659 63 64480005
Airway remodelling 22.67 13.56 6 18658 170 64479898
Conjunctival ulcer 22.64 13.56 5 18659 64 64480004
Bone disorder 22.52 13.56 26 18638 16733 64463335
Joint swelling 22.02 13.56 18 18646 215364 64264704
Disseminated intravascular coagulation 21.87 13.56 36 18628 32312 64447756
Breast swelling 21.82 13.56 9 18655 1039 64479029
Androgens increased 21.45 13.56 3 18661 0 64480068
Metastases to eye 21.18 13.56 6 18658 220 64479848
Acute coronary syndrome 21.13 13.56 27 18637 19283 64460785
Bone debridement 21.10 13.56 7 18657 438 64479630
Decreased appetite 20.81 13.56 146 18518 281143 64198925
Tooth extraction 20.32 13.56 19 18645 9582 64470486
Atopy 20.26 13.56 6 18658 258 64479810
Cardiac septal defect 20.17 13.56 6 18658 262 64479806
Phyllodes tumour 20.16 13.56 4 18660 29 64480039
Drug intolerance 20.12 13.56 15 18649 187977 64292091
Orchidectomy 20.04 13.56 4 18660 30 64480038
Hyperadrenalism 19.60 13.56 4 18660 34 64480034
Platelet count decreased 19.47 13.56 98 18566 167613 64312455
Breast tenderness 18.85 13.56 10 18654 2039 64478029
Abdominal pain upper 18.68 13.56 14 18650 175016 64305052
Rash 18.68 13.56 69 18595 458480 64021588
Bone pain 18.64 13.56 42 18622 47530 64432538
Hypogonadism 18.58 13.56 8 18656 1027 64479041
Polyneuropathy in malignant disease 18.46 13.56 5 18659 155 64479913
Product name confusion 18.34 13.56 5 18659 159 64479909
Ventricular fibrillation 18.12 13.56 28 18636 23832 64456236
Penile oedema 17.77 13.56 5 18659 179 64479889
Osteomyelitis 17.71 13.56 30 18634 27557 64452511
Spinal cord compression 17.59 13.56 14 18650 5689 64474379
Breakthrough pain 17.32 13.56 8 18656 1212 64478856
Off label use 16.69 13.56 111 18553 632695 63847373
Metastases to breast 16.35 13.56 5 18659 240 64479828
Vipoma 16.25 13.56 3 18661 14 64480054
Radical prostatectomy 16.25 13.56 3 18661 14 64480054
Subdural haematoma 16.05 13.56 29 18635 28025 64452043
Retroperitoneal lymphadenopathy 15.91 13.56 7 18657 947 64479121
Muscular weakness 15.91 13.56 76 18588 127262 64352806
Cerebral infarction 15.81 13.56 36 18628 41008 64439060
Injection site induration 15.76 13.56 16 18648 8916 64471152
Lower respiratory tract infection 15.70 13.56 4 18660 94610 64385458
Haemorrhage urinary tract 15.60 13.56 9 18655 2160 64477908
Bone cancer 15.57 13.56 8 18656 1527 64478541
Libido decreased 15.30 13.56 12 18652 4772 64475296
Product use issue 15.11 13.56 13 18651 151702 64328366
Poor peripheral circulation 14.72 13.56 10 18654 3190 64476878
Cough 14.69 13.56 42 18622 302106 64177962
Neuroendocrine carcinoma metastatic 14.61 13.56 5 18659 344 64479724
Bone trimming 14.55 13.56 3 18661 27 64480041
Bone sequestrum 14.53 13.56 7 18657 1165 64478903
Metastases to central nervous system 14.52 13.56 19 18645 13893 64466175
Troponin increased 14.49 13.56 20 18644 15379 64464689
Tooth loss 14.46 13.56 13 18651 6234 64473834
Cancer pain 14.32 13.56 11 18653 4246 64475822
Eye colour change 14.25 13.56 5 18659 371 64479697
Diabetes mellitus 14.25 13.56 47 18617 66427 64413641
Abdominal wall haematoma 14.21 13.56 11 18653 4294 64475774
Syncope 14.19 13.56 86 18578 157549 64322519
Anaesthesia 13.72 13.56 5 18659 414 64479654
Acquired gene mutation 13.64 13.56 8 18656 1978 64478090
Osteitis 13.61 13.56 10 18654 3612 64476456

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L02AE51 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONES AND RELATED AGENTS
Gonadotropin releasing hormone analogues
ATC L02BB03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ENDOCRINE THERAPY
HORMONE ANTAGONISTS AND RELATED AGENTS
Anti-androgens
FDA MoA N0000000243 Androgen Receptor Antagonists
FDA EPC N0000175560 Androgen Receptor Inhibitor
CHEBI has role CHEBI:35497 antiandrogen
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:35703 Xenobiotic
CHEBI has role CHEBI:78298 environmental contaminants
MeSH PA D000726 Androgen Antagonists
MeSH PA D000970 Antineoplastic Agents
MeSH PA D006727 Hormone Antagonists

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

DiseaseRelationSNOMED_IDDOID
Metastatic Prostate Carcinoma indication
Advanced Prostatic Carcinoma off-label use
Interstitial pneumonia contraindication 64667001
Diabetes mellitus contraindication 73211009 DOID:9351
Hyperglycemia contraindication 80394007 DOID:4195
Liver function tests abnormal contraindication 166603001
Disease of liver contraindication 235856003 DOID:409
Drug-induced hepatitis contraindication 235876009
Anemia contraindication 271737000 DOID:2355
Pregnancy, function contraindication 289908002




๐Ÿถ Veterinary Drug Use

None

๐Ÿถ Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.19 acidic
pKa2 11.84 acidic

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
Androgen receptor Nuclear hormone receptor ANTAGONIST Ki 7.72 CHEMBL CHEMBL
Cytochrome P450 2C19 Enzyme IC50 6 CHEMBL
Androgen receptor Transcription factor Ki 7.85 CHEMBL
Androgen receptor Transcription factor IC50 6.17 CHEMBL
Progesterone receptor Transcription factor IC50 5.25 CHEMBL
Progesterone receptor Transcription factor Ki 5.14 CHEMBL

External reference:

IDSource
4020950 VUID
N0000148428 NUI
D00961 KEGG_DRUG
151495 RXNORM
C0285590 UMLSCUI
CHEBI:3090 CHEBI
CHEMBL409 ChEMBL_ID
CHEMBL63560 ChEMBL_ID
DB01128 DRUGBANK_ID
C053541 MESH_SUPPLEMENTAL_RECORD_UI
2375 PUBCHEM_CID
2863 IUPHAR_LIGAND_ID
7021 INN_ID
A0Z3NAU9DP UNII
165839 MMSL
4282 MMSL
4824 MMSL
d03850 MMSL
005064 NDDF
108766001 SNOMEDCT_US
386908000 SNOMEDCT_US
4020950 VANDF

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 0904-6019 TABLET 50 mg ORAL ANDA 26 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 16714-816 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 16729-023 TABLET 50 mg ORAL ANDA 26 sections
bicalutamide Human Prescription Drug Label 1 47335-485 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
CASODEX HUMAN PRESCRIPTION DRUG LABEL 1 54868-4503 TABLET 50 mg ORAL NDA 25 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 54868-6133 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 60429-177 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 60429-177 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 60505-2642 TABLET 50 mg ORAL ANDA 26 sections
bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 62175-132 TABLET, FILM COATED 50 mg ORAL ANDA 26 sections
CASODEX HUMAN PRESCRIPTION DRUG LABEL 1 62559-680 TABLET 50 mg ORAL NDA 27 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 62559-890 TABLET 50 mg ORAL NDA 27 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 63629-8308 TABLET 50 mg ORAL ANDA 25 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 63672-0005 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 65841-613 TABLET, FILM COATED 50 mg ORAL ANDA 1 sections
bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 67253-191 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 68382-224 TABLET, FILM COATED 50 mg ORAL ANDA 28 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 70518-2993 TABLET 50 mg ORAL ANDA 25 sections
Bicalutamide HUMAN PRESCRIPTION DRUG LABEL 1 71205-577 TABLET 50 mg ORAL ANDA 26 sections