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

Stem definitionDrug idCAS RN
antibiotics, produced by Streptomyces strains 2684 32986-56-4

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • vantobra
  • tobramycin
  • Nebramycin 6
  • Nebramycin VI
  • tobracin
  • tobradistin
  • tobralex
  • tobramaxin
  • tobramicin
  • tobramycetin
  • tobramycin sulfate
  • nebcin
  • Tobi Podhaler
An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.
  • Molecular weight: 467.52
  • Formula: C18H37N5O9
  • CLOGP: -3.44
  • LIPINSKI: 2
  • HAC: 14
  • HDO: 10
  • TPSA: 268.17
  • ALOGS: -0.94
  • ROTB: 6

  • Status: OFP

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

Drug dosage:

DoseUnitRoute
0.11 g Inhal.powder
0.30 g Inhal.solution
0.24 g P

ADMET properties:

PropertyValueReference
BDDCS (Biopharmaceutical Drug Disposition Classification System) 3 Benet LZ, Broccatelli F, Oprea TI
S (Water solubility) 1000 mg/mL Benet LZ, Broccatelli F, Oprea TI
EoM (Fraction excreted unchanged in urine) 93 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 19.25 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 1 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.23 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 1.60 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 1 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 2 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Feb. 18, 2019 EMA PARI PHARMA GMBH
June 11, 1975 FDA

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
Cystic fibrosis 885.21 38.66 131 1814 379 2355761
Infective pulmonary exacerbation of cystic fibrosis 733.50 38.66 120 1825 768 2355372
Cough 400.84 38.66 147 1798 32970 2323170
Acute kidney injury 321.77 38.66 120 1825 28002 2328138
Condition aggravated 299.66 38.66 118 1827 31861 2324279
Pseudomonas infection 271.39 38.66 54 1891 1112 2355028
Hospitalisation 263.51 38.66 88 1857 14765 2341375
Pneumonia 231.98 38.66 112 1833 49184 2306956
Dyspnoea 203.65 38.66 120 1825 78613 2277527
Haemoptysis 202.06 38.66 52 1893 3475 2352665
Death 197.23 38.66 119 1826 81349 2274791
Pulmonary function test decreased 196.54 38.66 36 1909 465 2355675
Renal tubular necrosis 165.77 38.66 38 1907 1552 2354588
Bronchiectasis 161.57 38.66 34 1911 927 2355213
Eye irritation 135.87 38.66 38 1907 3474 2352666
Lung disorder 134.84 38.66 43 1902 6169 2349971
Tinnitus 130.06 38.66 40 1905 5095 2351045
Dysphonia 125.66 38.66 41 1904 6323 2349817
Ocular hyperaemia 121.65 38.66 36 1909 4020 2352120
Off label use 119.58 38.66 84 1861 73514 2282626
Bronchospasm 113.66 38.66 32 1913 2992 2353148
Chest discomfort 112.33 38.66 47 1898 14548 2341592
Forced expiratory volume decreased 107.37 38.66 22 1923 523 2355617
Endophthalmitis 99.37 38.66 22 1923 763 2355377
Wheezing 97.79 38.66 34 1911 6350 2349790
Ototoxicity 96.84 38.66 18 1927 252 2355888
Eye pain 94.43 38.66 31 1914 4860 2351280
Deafness 85.44 38.66 25 1920 2676 2353464
Drug level increased 84.67 38.66 25 1920 2762 2353378
Sputum increased 84.11 38.66 15 1930 164 2355976
Pyrexia 83.95 38.66 60 1885 53648 2302492
Corneal oedema 79.96 38.66 16 1929 336 2355804
Productive cough 76.33 38.66 27 1918 5294 2350846
Visual acuity reduced 72.65 38.66 26 1919 5272 2350868
Weight decreased 72.00 38.66 43 1902 28328 2327812
Conjunctival hyperaemia 71.37 38.66 16 1929 587 2355553
Product use issue 70.13 38.66 32 1913 12137 2344003
Staphylococcal infection 65.05 38.66 24 1921 5302 2350838
Malaise 64.44 38.66 52 1893 55533 2300607
Sputum discoloured 60.88 38.66 16 1929 1150 2354990
Uveitis 60.33 38.66 17 1928 1588 2354552
Aphonia 59.17 38.66 16 1929 1283 2354857
Blood creatinine increased 58.48 38.66 27 1918 10506 2345634
Infection 58.21 38.66 32 1913 17997 2338143
Drug ineffective 56.08 38.66 63 1882 101561 2254579
Disease complication 55.29 38.66 13 1932 590 2355550
Corneal perforation 50.66 38.66 9 1936 96 2356044
Drug hypersensitivity 50.56 38.66 42 1903 46601 2309539
Drug resistance 48.07 38.66 16 1929 2608 2353532
Intraocular pressure increased 47.84 38.66 14 1931 1495 2354645
Vision blurred 47.23 38.66 26 1919 14642 2341498
Product administered to patient of inappropriate age 46.95 38.66 12 1933 772 2355368
Photophobia 46.12 38.66 15 1930 2274 2353866
Ulcerative keratitis 45.53 38.66 11 1934 561 2355579
Eye disorder 44.87 38.66 16 1929 3203 2352937
Ocular hypertension 44.60 38.66 9 1936 197 2355943
Corneal opacity 44.43 38.66 9 1936 201 2355939
Hypoacusis 43.90 38.66 16 1929 3409 2352731
Nephropathy toxic 42.01 38.66 12 1933 1176 2354964
Pathogen resistance 41.30 38.66 11 1934 832 2355308
Tubulointerstitial nephritis 41.23 38.66 14 1931 2424 2353716
Keratitis 40.80 38.66 10 1935 542 2355598
Eye pruritus 40.72 38.66 14 1931 2517 2353623
Corneal infiltrates 40.38 38.66 7 1938 64 2356076
Hypopyon 40.19 38.66 8 1937 163 2355977
Bronchial wall thickening 39.90 38.66 7 1938 69 2356071
Drug reaction with eosinophilia and systemic symptoms 39.78 38.66 17 1928 5501 2350639

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
Cystic fibrosis 760.88 44.25 117 1535 302 1744827
Infective pulmonary exacerbation of cystic fibrosis 610.48 44.25 104 1548 595 1744534
Cough 342.40 44.25 124 1528 19073 1726056
Pseudomonas infection 247.22 44.25 54 1598 1250 1743879
Condition aggravated 241.61 44.25 99 1553 21051 1724078
Dyspnoea 231.93 44.25 127 1525 51932 1693197
Pneumonia 226.04 44.25 120 1532 46062 1699067
Hospitalisation 214.17 44.25 79 1573 12621 1732508
Acute kidney injury 202.83 44.25 102 1550 34842 1710287
Pulmonary function test decreased 182.34 44.25 35 1617 411 1744718
Eye pain 166.93 44.25 44 1608 2287 1742842
Death 153.37 44.25 119 1533 87324 1657805
Haemoptysis 151.28 44.25 48 1604 4828 1740301
Sputum increased 137.00 44.25 24 1628 161 1744968
Renal tubular necrosis 118.80 44.25 33 1619 2086 1743043
Endophthalmitis 115.41 44.25 26 1626 690 1744439
Sputum discoloured 111.38 44.25 25 1627 652 1744477
Productive cough 105.71 44.25 34 1618 3557 1741572
Forced expiratory volume decreased 105.24 44.25 22 1630 406 1744723
Bronchospasm 101.16 44.25 29 1623 2053 1743076
Malaise 98.19 44.25 60 1592 29505 1715624
Lung disorder 97.66 44.25 35 1617 5084 1740045
Intraocular pressure increased 97.55 44.25 25 1627 1156 1743973
Chest discomfort 92.33 44.25 37 1615 7294 1737835
Wheezing 89.12 44.25 31 1621 4122 1741007
Bronchiectasis 88.30 44.25 20 1632 543 1744586
Visual acuity reduced 87.21 44.25 30 1622 3858 1741271
Product administered to patient of inappropriate age 85.89 44.25 21 1631 799 1744330
Pyrexia 84.58 44.25 65 1587 46335 1698794
Ocular hyperaemia 80.03 44.25 24 1628 1986 1743143
Nephropathy toxic 79.11 44.25 23 1629 1709 1743420
Product use issue 76.91 44.25 34 1618 8537 1736592
Off label use 74.53 44.25 56 1596 38515 1706614
Pancreatic failure 70.20 44.25 13 1639 123 1745006
Tinnitus 69.10 44.25 24 1628 3171 1741958
Infection 67.94 44.25 35 1617 12325 1732804
Staphylococcal infection 63.54 44.25 25 1627 4682 1740447
Choroiditis 59.22 44.25 10 1642 52 1745077
Cystic fibrosis related diabetes 58.07 44.25 8 1644 5 1745124
Drug resistance 57.48 44.25 21 1631 3209 1741920
Uveitis 57.16 44.25 16 1636 1035 1744094
Asthma 52.30 44.25 22 1630 4882 1740247
Toxic epidermal necrolysis 51.98 44.25 18 1634 2353 1742776
Ototoxicity 50.04 44.25 11 1641 259 1744870
Infective exacerbation of bronchiectasis 49.09 44.25 8 1644 32 1745097
Ill-defined disorder 47.98 44.25 16 1636 1865 1743264
Obstructive airways disorder 47.86 44.25 14 1638 1060 1744069
Deafness 47.28 44.25 16 1636 1950 1743179
Eyelid oedema 45.08 44.25 14 1638 1299 1743830
Dysphonia 44.88 44.25 18 1634 3537 1741592

Pharmacologic Action:

SourceCodeDescription
ATC J01GB01 ANTIINFECTIVES FOR SYSTEMIC USE
ANTIBACTERIALS FOR SYSTEMIC USE
AMINOGLYCOSIDE ANTIBACTERIALS
Other aminoglycosides
ATC S01AA12 SENSORY ORGANS
OPHTHALMOLOGICALS
ANTIINFECTIVES
Antibiotics
FDA EPC N0000175477 Aminoglycoside Antibacterial
FDA CS M0000946 Aminoglycosides
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
Staphylococcal pneumonia indication 22754005
Pneumonia due to Pseudomonas indication 41381004
Punctate keratitis indication 42513006 DOID:12197
Pneumonia due to Escherichia coli indication 51530003
Blepharoconjunctivitis indication 68659002 DOID:2456
Infection due to Escherichia coli indication 71057007
Bacterial infection due to Serratia indication 71120004
Rhinoscleroma indication 72409005 DOID:11336
Perforation of cornea indication 74895004
Dacryocystitis indication 85777005 DOID:9938
Corneal abrasion indication 85848002
Keratoconjunctivitis indication 88151007 DOID:9368
Bacterial meningitis indication 95883001 DOID:9470
Infection of bone indication 111253001
Bacterial conjunctivitis indication 128350005 DOID:9700
Uveitis indication 128473001 DOID:13141
Infection due to Enterobacteriaceae indication 128945009
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Bacterial peritonitis indication 197171003
Sepsis of the newborn indication 206376005
Neonatal meningitis indication 276674008
Escherichia coli urinary tract infection indication 301011002
Meibomianitis indication 309779001
Bacterial urinary infection indication 312124009
Infective blepharitis indication 312219000
Herpes zoster keratitis indication 397573005
Rosacea indication 398909004 DOID:8881
Infection due to Staphylococcus aureus indication 406602003
Anterior uveitis indication 410692006 DOID:1407
Nosocomial pneumonia indication 425464007
Osteomyelitis due to Staphylococcus aureus indication 428783003
Sepsis due to Pseudomonas indication 448813005
Allergic conjunctivitis indication 473460002 DOID:11204
Urinary tract infection caused by Klebsiella indication 369001000119100
Synergy for Nosocomial Pneumonia due to Pseudomonas Aeruginosa indication
Synergy for Neonatal Meningitis indication
Klebsiella Pneumoniae Peritonitis indication
Proteus Mirabilis Osteomyelitis indication
E. Coli Osteomyelitis indication
Skin and Skin Structure Proteus Infection indication
Complicated UTI with Pseudomonas Aeruginosa indication
Gram-Negative Aerobic Bacillary Pneumonia indication
Klebsiella Pneumoniae Osteomyelitis indication
Synergy for Staphylococcal Infections indication
Staphylococcus Aureus Complicated UTI indication
Complicated Proteus UTI indication
Citrobacter Complicated UTI indication
Enterobacter Osteomyelitis indication
Synergy for P. Aeruginosa Infection in Cystic Fibrosis indication
E. Coli Peritonitis indication
Complicated Urinary Tract Infections indication
Synergy for Bacterial Meningitis indication
Skin and Skin Structure Pseudomonas Aeruginosa Infection indication
Enterobacter Pneumonia indication
Pseudomonas Aeruginosa Osteomyelitis indication
Serratia Complicated UTI indication
Providencia Complicated UTI indication
Pyrexia of unknown origin off-label use 7520000
Exposure keratoconjunctivitis off-label use 14366000 DOID:9461
Neuropathic corneal ulcer off-label use 231901007
Superficial Ocular Infection off-label use
Ocular hypertension contraindication 4210003 DOID:9282
Hypocalcemia contraindication 5291005
Herpes simplex keratitis contraindication 9389005
Glaucoma contraindication 23986001 DOID:1686
Herpes simplex dendritic keratitis contraindication 29943008
Fungal infection of eye contraindication 31194008
Parkinsonism contraindication 32798002
Dehydration contraindication 34095006
Severe myopia contraindication 34187009
Tuberculosis of eye contraindication 49107007
Tinnitus contraindication 60862001
Diabetes mellitus contraindication 73211009 DOID:9351
Open-angle glaucoma contraindication 84494001 DOID:1067
Krukenberg spindle contraindication 85430004
Herpes zoster ophthalmicus contraindication 87513003
Kidney disease contraindication 90708001 DOID:557
Myasthenia gravis contraindication 91637004 DOID:437
Eye infection contraindication 128351009
Bacterial infection of eye contraindication 128984004
Hypomagnesemia contraindication 190855004
Pregnancy, function contraindication 289908002
Viral eye infection contraindication 312132001
Vaccinia keratitis contraindication 397552005
Pseudomembranous enterocolitis contraindication 397683000
Vertigo contraindication 399153001
Infant Botulism contraindication
Disorder of the 8th Cranial Nerve contraindication
Tobramycin Toxicity contraindication

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 13.15 acidic
pKa2 13.85 acidic
pKa3 8.34 Basic
pKa4 7.59 Basic
pKa5 6.94 Basic
pKa6 6.81 Basic
pKa7 5.55 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
300MG/4ML BETHKIS CHIESI N201820 Oct. 12, 2012 RX SOLUTION INHALATION 7939502 June 14, 2022 MANAGEMENT OF CYSTIC FIBROSIS PATIENTS
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 7368102 Dec. 19, 2022 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8715623 Dec. 19, 2022 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 9421166 Dec. 19, 2022 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8664187 June 20, 2025 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
0.3% TOBRADEX ST EYEVANCE N050818 Feb. 13, 2009 RX SUSPENSION/DROPS OPHTHALMIC 8101582 Dec. 19, 2027 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
0.3% TOBRADEX ST EYEVANCE N050818 Feb. 13, 2009 RX SUSPENSION/DROPS OPHTHALMIC 7795316 Aug. 3, 2028 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION WHERE AN INFECTION OR RISK OF INFECTION EXISTS
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 8869794 Sept. 12, 2028 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
28MG TOBI PODHALER MYLAN SPECIALITY LP N201688 March 22, 2013 RX POWDER INHALATION 10207066 Nov. 4, 2030 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Macrolide 2'-phosphotransferase II; Macrolide 2'-phosphotransferase II protein MphB; Macrolide 2-phosphotransferase, mph(B) Enzyme Km 5.82 WOMBAT-PK

External reference:

IDSource
4018595 VUID
N0000146911 NUI
C0040341 UMLSCUI
D00063 KEGG_DRUG
89695009 SNOMEDCT_US
4018595 VANDF
1090 MMSL
10627 RXNORM
373548001 SNOMEDCT_US
5590 MMSL
d00069 MMSL
002779 NDDF
DB00684 DRUGBANK_ID
CHEMBL1747 ChEMBL_ID
CHEMBL1200780 ChEMBL_ID
HJT0RXD7JK UNII
49842-07-1 SECONDARY_CAS_RN
2990 INN_ID
TOY PDB_CHEM_ID
CHEBI:73678 CHEBI
D014031 MESH_DESCRIPTOR_UI
CHEMBL3989564 ChEMBL_ID
36294 PUBCHEM_CID

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Tobrex HUMAN PRESCRIPTION DRUG LABEL 1 0065-0643 SOLUTION/ DROPS 3 mg OPHTHALMIC NDA 10 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 0065-0644 OINTMENT 3 mg OPHTHALMIC NDA 10 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0647 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 10 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 0065-0648 OINTMENT 3 mg OPHTHALMIC NDA 12 sections
TOBRADEX ST HUMAN PRESCRIPTION DRUG LABEL 2 0065-0652 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 14 sections
TOBI HUMAN PRESCRIPTION DRUG LABEL 1 0078-0494 SOLUTION 300 mg ORAL NDA 19 sections
TOBI Podhaler HUMAN PRESCRIPTION DRUG LABEL 1 0078-0630 CAPSULE 28 mg ORAL NDA 19 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0093-4085 SOLUTION 300 mg RESPIRATORY (INHALATION) ANDA 19 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0404-7196 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 12 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3577 INJECTION, SOLUTION 10 mg INTRAMUSCULAR ANDA 13 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0409-3578 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 13 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 0781-7171 SOLUTION 300 mg ORAL NDA authorized generic 13 sections
BETHKIS HUMAN PRESCRIPTION DRUG LABEL 1 10122-820 SOLUTION 300 mg RESPIRATORY (INHALATION) NDA 19 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 10544-883 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 13 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 13985-604 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 13 sections
TOBRADEX HUMAN PRESCRIPTION DRUG LABEL 2 16590-223 SUSPENSION 3 mg OPHTHALMIC NDA 12 sections
TOBRAMYCIN HUMAN PRESCRIPTION DRUG LABEL 1 16590-224 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 13 sections
TOBREX HUMAN PRESCRIPTION DRUG LABEL 1 16590-225 OINTMENT 3 mg OPHTHALMIC NDA 11 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 17478-114 INJECTION, SOLUTION 40 mg INTRAMUSCULAR ANDA 13 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 17478-290 SOLUTION/ DROPS 3 mg OPHTHALMIC ANDA 13 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 17478-340 SOLUTION 300 mg ORAL ANDA 19 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 21695-203 SUSPENSION 3 mg OPHTHALMIC NDA 11 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 21695-204 SOLUTION 3 mg OPHTHALMIC ANDA 11 sections
Tobramycin and Dexamethasone HUMAN PRESCRIPTION DRUG LABEL 2 21695-416 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 12 sections
Tobrex HUMAN PRESCRIPTION DRUG LABEL 1 21695-458 OINTMENT 3 mg OPHTHALMIC NDA 11 sections
TobraDex HUMAN PRESCRIPTION DRUG LABEL 2 21695-628 OINTMENT 3 mg OPHTHALMIC NDA 11 sections
Tobramycin HUMAN PRESCRIPTION DRUG LABEL 1 24208-290 SOLUTION 3 mg OPHTHALMIC ANDA 12 sections
Tobramycin and Dexamethasone HUMAN PRESCRIPTION DRUG LABEL 2 24208-295 SUSPENSION/ DROPS 3 mg OPHTHALMIC ANDA 12 sections
Zylet HUMAN PRESCRIPTION DRUG LABEL 2 24208-358 SUSPENSION/ DROPS 3 mg OPHTHALMIC NDA 13 sections
Kitabis Pak HUMAN PRESCRIPTION DRUG LABEL 1 24492-850 SOLUTION 300 mg RESPIRATORY (INHALATION) NDA 19 sections