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

Stem definitionDrug idCAS RN
tyrosine kinase inhibitors 4318 850140-72-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • afatinib
  • tovok
  • afatinib dimaleate
  • gilotrif
  • BIBW2992
  • afatinib maleate
A quinazoline and butenamide derivative that acts as a tyrosine kinase inhibitor of epidermal growth factor receptors (ERBB RECEPTORS) and is used in the treatment of metastatic NON-SMALL CELL LUNG CANCER.
  • Molecular weight: 485.94
  • Formula: C24H25ClFN5O3
  • CLOGP: 4.34
  • LIPINSKI: 0
  • HAC: 8
  • HDO: 2
  • TPSA: 88.61
  • ALOGS: -4.58
  • ROTB: 8

  • Status: ONP

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

Drug dosage:

DoseUnitRoute
40 mg O

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Hosey CM, Chan R, Benet LZ
S (Water solubility) 14.36 mg/mL Bocci G, Oprea TI, Benet LZ

Approvals:

DateAgencyCompanyOrphan
Sept. 25, 2013 EMA
July 12, 2013 FDA BOEHRINGER INGELHEIM

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
Malignant neoplasm progression 1866.95 28.61 616 8301 81505 63398600
Diarrhoea 1250.20 28.61 917 8000 714449 62765656
Paronychia 796.22 28.61 179 8738 5386 63474719
Metastases to central nervous system 346.55 28.61 111 8806 12994 63467111
Stomatitis 273.07 28.61 194 8723 138531 63341574
Dermatitis acneiform 225.77 28.61 64 8853 4932 63475173
Rash 220.74 28.61 327 8590 560544 62919561
Decreased appetite 182.16 28.61 199 8718 250853 63229252
Metastases to meninges 157.72 28.61 42 8875 2560 63477545
Dehydration 153.50 28.61 153 8764 173201 63306904
Skin toxicity 145.63 28.61 45 8872 4669 63475436
EGFR gene mutation 115.96 28.61 22 8895 275 63479830
Acne 100.82 28.61 54 8863 23239 63456866
Pleural effusion 87.39 28.61 85 8832 93125 63386980
Dry skin 85.80 28.61 68 8849 56819 63423286
Drug resistance 71.75 28.61 43 8874 22890 63457215
Skin fissures 65.53 28.61 32 8885 11356 63468749
Metastases to bone 64.69 28.61 39 8878 20980 63459125
Mucosal inflammation 64.20 28.61 53 8864 46875 63433230
Vomiting 63.41 28.61 197 8720 559420 62920685
Death 62.49 28.61 152 8765 374229 63105876
Skin disorder 59.50 28.61 42 8875 29465 63450640
Nail disorder 58.63 28.61 31 8886 12984 63467121
Metastases to liver 58.02 28.61 38 8879 23601 63456504
Interstitial lung disease 51.61 28.61 53 8864 61855 63418250
Metastases to lung 50.82 28.61 28 8889 12722 63467383
Acquired gene mutation 50.82 28.61 14 8903 969 63479136
Therapy partial responder 49.75 28.61 26 8891 10632 63469473
Small cell lung cancer 47.81 28.61 15 8902 1634 63478471
Arthralgia 45.51 28.61 12 8905 569698 62910407
Disease progression 41.33 28.61 67 8850 122691 63357414
Cutaneous symptom 39.57 28.61 9 8908 283 63479822
Gene mutation 39.48 28.61 13 8904 1652 63478453
Epistaxis 38.13 28.61 49 8868 72676 63407429
Onychoclasis 37.34 28.61 18 8899 6204 63473901
Nausea 35.16 28.61 222 8695 854249 62625856
Condition aggravated 35.01 28.61 7 8910 402210 63077895
Pneumonitis 34.62 28.61 33 8884 35189 63444916
Oral pain 34.56 28.61 30 8887 28364 63451741
Neoplasm progression 31.82 28.61 32 8885 36396 63443709
Rash pustular 31.82 28.61 17 8900 7265 63472840
Prerenal failure 31.40 28.61 11 8906 1685 63478420
Pain 30.08 28.61 36 8881 740592 62739513

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
Malignant neoplasm progression 1324.12 33.74 474 4096 87572 34864789
Diarrhoea 592.40 33.74 447 4123 389465 34562896
Paronychia 357.39 33.74 84 4486 3321 34949040
Metastases to central nervous system 279.75 33.74 83 4487 8122 34944239
Rash 262.21 33.74 222 4348 222530 34729831
Stomatitis 228.15 33.74 111 4459 42403 34909958
EGFR gene mutation 128.94 33.74 22 4548 155 34952206
Dermatitis acneiform 113.11 33.74 39 4531 6150 34946211
Interstitial lung disease 92.68 33.74 73 4497 65209 34887152
Decreased appetite 87.63 33.74 108 4462 166284 34786077
Skin toxicity 60.59 33.74 23 4547 4761 34947600
Acne 53.54 33.74 27 4543 11039 34941322
Lymphangiosis carcinomatosa 52.56 33.74 14 4556 918 34951443
Metastases to bone 51.53 33.74 27 4543 11943 34940418
Metastases to meninges 50.74 33.74 15 4555 1439 34950922
Pleural effusion 46.12 33.74 55 4515 81491 34870870
Dehydration 44.99 33.74 69 4501 129900 34822461
Drug resistance 34.58 33.74 28 4542 25899 34926462
Nail disorder 33.74 33.74 12 4558 2067 34950294

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
Malignant neoplasm progression 2677.53 24.52 936 11333 135054 79597065
Diarrhoea 1567.22 24.52 1185 11084 879304 78852815
Paronychia 1029.56 24.52 239 12030 7569 79724550
Metastases to central nervous system 474.62 24.52 152 12117 16223 79715896
Stomatitis 440.15 24.52 276 11993 146481 79585638
Rash 415.73 24.52 475 11794 577883 79154236
Dermatitis acneiform 323.63 24.52 101 12168 9892 79722227
EGFR gene mutation 245.24 24.52 45 12224 419 79731700
Decreased appetite 227.50 24.52 271 11998 342147 79389972
Metastases to meninges 184.84 24.52 52 12217 3549 79728570
Skin toxicity 183.94 24.52 63 12206 8251 79723868
Dehydration 152.39 24.52 189 12080 247998 79484121
Acne 128.76 24.52 69 12200 27121 79704998
Interstitial lung disease 116.61 24.52 113 12156 112487 79619632
Pleural effusion 109.53 24.52 123 12146 145139 79586980
Metastases to bone 101.86 24.52 57 12212 24370 79707749
Dry skin 89.35 24.52 78 12191 67917 79664202
Drug resistance 89.06 24.52 64 12205 42149 79689970
Metastases to liver 86.40 24.52 54 12215 28260 79703859
Lymphangiosis carcinomatosa 74.87 24.52 23 12246 2131 79729988
Therapy partial responder 73.63 24.52 41 12228 17356 79714763
Nail disorder 73.25 24.52 36 12233 11816 79720303
Small cell lung cancer 72.27 24.52 24 12245 2856 79729263
Skin fissures 67.04 24.52 35 12234 13038 79719081
Metastases to lung 64.02 24.52 38 12231 18125 79713994
Vomiting 62.45 24.52 234 12035 665594 79066525
Mucosal inflammation 62.09 24.52 67 12202 75513 79656606
Gene mutation 58.02 24.52 20 12249 2666 79729453
Acquired gene mutation 57.60 24.52 19 12250 2214 79729905
Skin disorder 52.94 24.52 43 12226 33900 79698219
Rash pustular 48.80 24.52 27 12242 11284 79720835
Cutaneous symptom 47.72 24.52 12 12257 530 79731589
Death 43.32 24.52 187 12082 566327 79165792
Arthralgia 43.24 24.52 17 12252 571786 79160333
Nausea 39.72 24.52 267 12002 956929 78775190
Condition aggravated 39.38 24.52 14 12255 501110 79231009
Malignant neoplasm of pleura 37.86 24.52 8 12261 161 79731958
Onychoclasis 34.63 24.52 17 12252 5561 79726558
Neoplasm progression 34.25 24.52 41 12228 51641 79680478
Epistaxis 33.61 24.52 61 12208 111454 79620665
Disease progression 32.47 24.52 81 12188 184281 79547838
Drug ineffective 31.92 24.52 75 12194 1080838 78651281
Metastases to pleura 31.36 24.52 11 12258 1543 79730576
Lung adenocarcinoma 29.15 24.52 17 12252 7847 79724272
Pneumonitis 28.95 24.52 41 12228 60819 79671300
Drug interaction 28.73 24.52 14 12255 415169 79316950
Gastrointestinal toxicity 28.66 24.52 17 12252 8092 79724027
Prerenal failure 28.25 24.52 13 12256 3685 79728434
Dysgeusia 27.91 24.52 39 12230 57138 79674981
Small cell carcinoma 27.58 24.52 7 12262 321 79731798
Product dose omission issue 27.51 24.52 3 12266 247534 79484585
Pain 26.69 24.52 42 12227 703760 79028359
Cheilitis 26.52 24.52 14 12255 5327 79726792
Malignant transformation 26.04 24.52 9 12260 1209 79730910
Angular cheilitis 25.90 24.52 8 12261 754 79731365
Metastasis 25.83 24.52 15 12254 6865 79725254
Toxicity to various agents 25.19 24.52 17 12252 421523 79310596
Joint swelling 24.53 24.52 7 12262 288639 79443480

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01EB03 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
PROTEIN KINASE INHIBITORS
Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
FDA MoA N0000175076 Protein Kinase Inhibitors
MeSH PA D000970 Antineoplastic Agents
MeSH PA D004791 Enzyme Inhibitors
MeSH PA D047428 Protein Kinase Inhibitors
FDA EPC N0000175605 Kinase Inhibitor
CHEBI has role CHEBI:35610 antineoplastic agents
CHEBI has role CHEBI:38637 tyrosine kinase inhibitors

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

DiseaseRelationSNOMED_IDDOID
Non-small cell lung cancer, positive for epidermal growth factor receptor expression indication 426964009




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 11.1 acidic
pKa2 8.94 Basic
pKa3 4.09 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL 9539258 Nov. 9, 2026 TREATMENT OF PATIENTS WITH ADVANCED (METASTATIC) NON-SMALL CELL LUNG CANCER WHOSE DISEASE PROGRESSED DURING OR AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL 9539258 Nov. 9, 2026 TREATMENT OF PATIENTS WITH ADVANCED (METASTATIC) NON-SMALL CELL LUNG CANCER WHOSE DISEASE PROGRESSED DURING OR AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL 9539258 Nov. 9, 2026 TREATMENT OF PATIENTS WITH ADVANCED (METASTATIC) NON-SMALL CELL LUNG CANCER WHOSE DISEASE PROGRESSED DURING OR AFTER PLATINUM-BASED CHEMOTHERAPY

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL April 15, 2023 TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL April 15, 2023 TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL April 15, 2023 TREATMENT OF PATIENTS WITH METASTATIC, SQUAMOUS, NON-SMALL CELL LUNG CANCER PROGRESSING AFTER PLATINUM-BASED CHEMOTHERAPY
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Oct. 15, 2023 PEDIATRIC EXCLUSIVITY
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Oct. 15, 2023 PEDIATRIC EXCLUSIVITY
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Oct. 15, 2023 PEDIATRIC EXCLUSIVITY
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Jan. 12, 2025 FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Jan. 12, 2025 FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Jan. 12, 2025 FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL April 7, 2025 REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTSFROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL April 7, 2025 REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTSFROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL April 7, 2025 REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTSFROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL July 12, 2025 PEDIATRIC EXCLUSIVITY
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL July 12, 2025 PEDIATRIC EXCLUSIVITY
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL July 12, 2025 PEDIATRIC EXCLUSIVITY
EQ 20MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Oct. 7, 2025 PEDIATRIC EXCLUSIVITY
EQ 30MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Oct. 7, 2025 PEDIATRIC EXCLUSIVITY
EQ 40MG BASE GILOTRIF BOEHRINGER INGELHEIM N201292 July 12, 2013 RX TABLET ORAL Oct. 7, 2025 PEDIATRIC EXCLUSIVITY

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Epidermal growth factor receptor Kinase INHIBITOR Kd 10 CHEMBL CHEMBL
Receptor tyrosine-protein kinase erbB-4 Kinase INHIBITOR Kd 8.20 CHEMBL CHEMBL
Receptor tyrosine-protein kinase erbB-2 Kinase INHIBITOR Kd 8.30 CHEMBL CHEMBL
Tyrosine-protein kinase Lck Kinase Kd 6.24 CHEMBL
Receptor-type tyrosine-protein kinase FLT3 Kinase Kd 5.85 CHEMBL
Phosphorylase b kinase gamma catalytic chain, liver/testis isoform Kinase Kd 6.33 CHEMBL
Myosin light chain kinase, smooth muscle Kinase Kd 4.50 CHEMBL
Tyrosine-protein kinase HCK Kinase Kd 5.66 CHEMBL
Mitogen-activated protein kinase 10 Kinase Kd 5.70 CHEMBL
Hepatocyte growth factor receptor Kinase Kd 5.66 CHEMBL
Phosphorylase b kinase gamma catalytic chain, skeletal muscle/heart isoform Kinase Kd 5.89 CHEMBL
Serine/threonine-protein kinase 10 Kinase Kd 5.37 CHEMBL
Mitogen-activated protein kinase 11 Kinase Kd 5.55 CHEMBL
Serine/threonine-protein kinase 17A Kinase Kd 5.64 CHEMBL
Ephrin type-A receptor 6 Kinase Kd 6.47 CHEMBL
Casein kinase I isoform epsilon Kinase Kd 5.89 CHEMBL
Mitogen-activated protein kinase 14 Kinase Kd 5.89 CHEMBL
Tyrosine-protein kinase FRK Kinase Kd 5.85 CHEMBL
Cyclin-G-associated kinase Kinase Kd 7.10 CHEMBL
Receptor-interacting serine/threonine-protein kinase 2 Kinase Kd 5.57 CHEMBL
STE20-like serine/threonine-protein kinase Kinase Kd 5.43 CHEMBL
MAP kinase-interacting serine/threonine-protein kinase 2 Kinase Kd 5.80 CHEMBL
Mitogen-activated protein kinase 9 Kinase Kd 5.68 CHEMBL
MAP kinase-activated protein kinase 2 Kinase Kd 6.09 CHEMBL
Tyrosine-protein kinase receptor UFO Kinase Kd 5.28 CHEMBL
Ribosomal protein S6 kinase alpha-6 Kinase Kd 5.51 CHEMBL
Tyrosine-protein kinase TXK Kinase Kd 5.51 CHEMBL
Dual specificity tyrosine-phosphorylation-regulated kinase 1B Kinase Kd 5.55 CHEMBL
MAP kinase-interacting serine/threonine-protein kinase 1 Kinase Kd 5.74 CHEMBL
Tyrosine-protein kinase Blk Kinase Kd 6.66 CHEMBL
Citron Rho-interacting kinase Kinase Kd 5.54 CHEMBL
Dual specificity tyrosine-phosphorylation-regulated kinase 1A Kinase Kd 6.01 CHEMBL
Dual specificity tyrosine-phosphorylation-regulated kinase 2 Kinase Kd 5.74 CHEMBL
Ephrin type-B receptor 6 Kinase Kd 5.51 CHEMBL
Homeodomain-interacting protein kinase 4 Kinase Kd 6.44 CHEMBL
Interleukin-1 receptor-associated kinase 1 Kinase Kd 6.62 CHEMBL
Receptor tyrosine-protein kinase erbB-3 Kinase Kd 5.35 CHEMBL
Serine/threonine-protein kinase SBK1 Kinase Kd 5.32 CHEMBL
Adenosine kinase Kinase Kd 5.46 CHEMBL
Dual specificity mitogen-activated protein kinase kinase 5 Kinase Kd 5.89 CHEMBL
Tyrosine-protein kinase ABL1 Kinase Kd 6.64 CHEMBL
Proto-oncogene tyrosine-protein kinase Src Kinase Kd 5.55 CHEMBL

External reference:

IDSource
4032662 VUID
N0000188388 NUI
D09724 KEGG_DRUG
850140-73-7 SECONDARY_CAS_RN
4032662 VANDF
4032663 VANDF
C2987648 UMLSCUI
CHEBI:61390 CHEBI
0WM PDB_CHEM_ID
CHEMBL1173655 ChEMBL_ID
D000077716 MESH_DESCRIPTOR_UI
DB08916 DRUGBANK_ID
5667 IUPHAR_LIGAND_ID
9230 INN_ID
41UD74L59M UNII
10184653 PUBCHEM_CID
1430268 RXNORM
204142 MMSL
29566 MMSL
d08113 MMSL
015117 NDDF
015118 NDDF
703579002 SNOMEDCT_US
703580004 SNOMEDCT_US
703582007 SNOMEDCT_US
CHEMBL2105712 ChEMBL_ID
CHEMBL2347958 ChEMBL_ID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0137 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0137 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0137 TABLET, FILM COATED 30 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0138 TABLET, FILM COATED 40 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0138 TABLET, FILM COATED 40 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0138 TABLET, FILM COATED 40 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0141 TABLET, FILM COATED 20 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0141 TABLET, FILM COATED 20 mg ORAL NDA 31 sections
Gilotrif HUMAN PRESCRIPTION DRUG LABEL 1 0597-0141 TABLET, FILM COATED 20 mg ORAL NDA 31 sections