clavulanic acid Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
beta-lactamase inhibitors 669 58001-44-8

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • clavulanic acid
  • clavulanate
  • clavulanate potassium
  • clavulante potasium
  • clavulanate potassium salt
A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase.
  • Molecular weight: 199.16
  • Formula: C8H9NO5
  • CLOGP: -1.07
  • LIPINSKI: 0
  • HAC: 6
  • HDO: 2
  • TPSA: 87.07
  • ALOGS: 0.23
  • 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
EoM (Fraction excreted unchanged in urine) 43 % Benet LZ, Broccatelli F, Oprea TI
MRTD (Maximum Recommended Therapeutic Daily Dose) 31.38 ┬ÁM/kg/day Contrera JF, Matthews EJ, Kruhlak NL, Benz RD
BA (Bioavailability) 75 % Kim MT, Sedykh A, Chakravarti SK, Saiakhov RD, Zhu H
Vd (Volume of distribution) 0.22 L/kg Lombardo F, Berellini G, Obach RS
CL (Clearance) 3.10 mL/min/kg Lombardo F, Berellini G, Obach RS
fu (Fraction unbound in plasma) 0.91 % Lombardo F, Berellini G, Obach RS
t_half (Half-life) 0.90 hours Lombardo F, Berellini G, Obach RS

Approvals:

DateAgencyCompanyOrphan
Aug. 6, 1984 FDA DR REDDYS LABS INC

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
Drug hypersensitivity 2843.40 38.71 746 1878 45897 2309564
Cholestasis 445.20 38.71 105 2519 3616 2351845
Rash 395.91 38.71 188 2436 59370 2296091
Drug reaction with eosinophilia and systemic symptoms 332.35 38.71 90 2534 5428 2350033
Hepatocellular injury 330.01 38.71 84 2540 3971 2351490
Rash maculo-papular 306.60 38.71 80 2544 4172 2351289
Acute kidney injury 292.72 38.71 122 2502 28000 2327461
Pruritus 290.51 38.71 138 2486 43202 2312259
Diarrhoea 260.90 38.71 160 2464 83404 2272057
Hepatitis cholestatic 249.76 38.71 53 2571 1104 2354357
Erythema 244.34 38.71 104 2520 25055 2330406
Pyrexia 156.95 38.71 99 2525 53609 2301852
Hepatitis 152.41 38.71 51 2573 6286 2349175
Vomiting 151.65 38.71 108 2516 71494 2283967
Anaphylactic reaction 149.18 38.71 56 2568 9649 2345812
Urticaria 145.91 38.71 72 2552 24189 2331272
Toxic skin eruption 145.82 38.71 39 2585 2221 2353240
Clostridium difficile colitis 144.24 38.71 38 2586 2041 2353420
Toxic epidermal necrolysis 137.50 38.71 40 2584 3104 2352357
Acute generalised exanthematous pustulosis 132.91 38.71 34 2590 1624 2353837
Jaundice 131.11 38.71 44 2580 5464 2349997
Agranulocytosis 112.14 38.71 35 2589 3447 2352014
Eosinophilia 108.98 38.71 33 2591 2937 2352524
Bone erosion 105.51 38.71 23 2601 543 2354918
Anaphylactic shock 104.99 38.71 35 2589 4251 2351210
Neutropenia 100.63 38.71 54 2570 21494 2333967
Liver injury 99.19 38.71 29 2595 2285 2353176
Transaminases increased 98.76 38.71 34 2590 4553 2350908
Drug-induced liver injury 97.79 38.71 32 2592 3667 2351794
Nausea 94.49 38.71 100 2524 112089 2243372
Bronchiectasis 93.39 38.71 23 2601 938 2354523
Anaemia 79.10 38.71 55 2569 34737 2320724
Stevens-Johnson syndrome 78.01 38.71 28 2596 4231 2351230
Face oedema 76.26 38.71 27 2597 3921 2351540
Synovitis 73.72 38.71 24 2600 2702 2352759
Hypersensitivity 72.36 38.71 45 2579 23548 2331913
Hypothyroidism 69.40 38.71 26 2598 4431 2351030
Loss of personal independence in daily activities 68.46 38.71 27 2597 5284 2350177
Thrombocytopenia 67.68 38.71 40 2584 19091 2336370
Blood alkaline phosphatase increased 66.33 38.71 28 2596 6517 2348944
Drug intolerance 65.70 38.71 35 2589 13682 2341779
Alanine aminotransferase increased 64.96 38.71 35 2589 13997 2341464
Mixed liver injury 64.88 38.71 14 2610 314 2355147
Dyspnoea 63.94 38.71 69 2555 78664 2276797
Aspartate aminotransferase increased 62.72 38.71 33 2591 12579 2342882
Drug ineffective 60.68 38.71 76 2548 101548 2253913
Status epilepticus 55.76 38.71 19 2605 2459 2353002
Hyperkalaemia 55.70 38.71 24 2600 5869 2349592
Protein C increased 54.18 38.71 8 2616 14 2355447
Hypotension 52.82 38.71 42 2582 32394 2323067
Dehydration 52.36 38.71 36 2588 22259 2333202
Pneumonia 52.34 38.71 50 2574 49246 2306215
C-reactive protein increased 51.11 38.71 23 2601 6232 2349229
Dermatitis exfoliative 50.73 38.71 15 2609 1226 2354235
Skin exfoliation 49.58 38.71 22 2602 5768 2349693
Oliguria 49.41 38.71 15 2609 1342 2354119
Purpura 49.19 38.71 16 2608 1794 2353667
Leukopenia 48.75 38.71 26 2598 10170 2345291
Blood bilirubin increased 48.00 38.71 21 2603 5324 2350137
Linear IgA disease 47.50 38.71 11 2613 343 2355118
Shock 46.88 38.71 19 2605 3985 2351476
Induced abortion failed 46.71 38.71 8 2616 48 2355413
Candida infection 45.58 38.71 17 2607 2856 2352605
Odynophagia 45.26 38.71 13 2611 959 2354502
Cholestatic liver injury 44.81 38.71 10 2614 263 2355198
Lymphadenopathy 43.55 38.71 20 2604 5678 2349783
Acute hepatic failure 43.26 38.71 16 2608 2626 2352835
Renal failure 43.05 38.71 29 2595 17320 2338141
Rash erythematous 42.64 38.71 20 2604 5956 2349505
Drug abuse 42.11 38.71 25 2599 12001 2343460
Tachycardia 42.09 38.71 28 2596 16381 2339080
Cardiac arrest 42.02 38.71 27 2597 14903 2340558
Angioedema 41.80 38.71 22 2602 8374 2347087
International normalised ratio increased 41.65 38.71 21 2603 7315 2348146
Asthenia 41.29 38.71 43 2581 46883 2308578
Gamma-glutamyltransferase increased 40.87 38.71 19 2605 5543 2349918
Lymphopenia 40.69 38.71 15 2609 2439 2353022
Allergic hepatitis 40.11 38.71 6 2618 12 2355449
Hyperthermia 39.98 38.71 13 2611 1455 2354006
Enanthema 39.63 38.71 8 2616 128 2355333
Abdominal pain upper 38.93 38.71 30 2594 22070 2333391
Condition aggravated 38.85 38.71 35 2589 31944 2323517

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
Hepatocellular injury 460.65 43.91 109 1831 3122 1741719
Drug hypersensitivity 453.67 43.91 150 1790 14985 1729856
Cholestasis 452.11 43.91 110 1830 3555 1741286
Rash maculo-papular 259.52 43.91 71 1869 3632 1741209
Jaundice 250.23 43.91 77 1863 5985 1738856
Hepatitis 230.35 43.91 69 1871 4886 1739955
Drug reaction with eosinophilia and systemic symptoms 224.47 43.91 68 1872 5002 1739839
Rash 218.72 43.91 117 1823 38576 1706265
Drug-induced liver injury 217.13 43.91 60 1880 3177 1741664
Pruritus 185.77 43.91 89 1851 23133 1721708
Hepatitis cholestatic 174.28 43.91 42 1898 1279 1743562
Erythema 152.88 43.91 67 1873 14121 1730720
Pyrexia 147.63 43.91 97 1843 46303 1698538
Acute kidney injury 143.60 43.91 86 1854 34858 1709983
Mixed liver injury 129.98 43.91 25 1915 248 1744593
Eosinophilia 116.95 43.91 38 1902 3489 1741352
Diarrhoea 114.19 43.91 88 1852 53764 1691077
Urticaria 113.19 43.91 52 1888 12189 1732652
Purpura 110.14 43.91 31 1909 1743 1743098
Liver injury 108.33 43.91 31 1909 1851 1742990
Jaundice cholestatic 106.36 43.91 26 1914 838 1744003
Thrombocytopenia 104.77 43.91 59 1881 21190 1723651
Vomiting 102.21 43.91 72 1868 38243 1706598
Toxic skin eruption 99.40 43.91 29 1911 1854 1742987
Pancytopenia 97.96 43.91 46 1894 11311 1733530
Agranulocytosis 92.61 43.91 32 1908 3544 1741297
Anaphylactic reaction 82.67 43.91 34 1906 6079 1738762
Blood bilirubin increased 82.16 43.91 34 1906 6176 1738665
Clostridium difficile colitis 81.55 43.91 24 1916 1580 1743261
Neutropenia 77.39 43.91 46 1894 18214 1726627
Stevens-Johnson syndrome 75.29 43.91 27 1913 3330 1741511
Transaminases increased 74.86 43.91 28 1912 3889 1740952
Dyspnoea 74.63 43.91 68 1872 51991 1692850
Nausea 67.78 43.91 64 1876 51132 1693709
Anaphylactic shock 67.58 43.91 24 1916 2875 1741966
Blood alkaline phosphatase increased 67.19 43.91 28 1912 5167 1739674
Alanine aminotransferase increased 65.58 43.91 36 1904 12242 1732599
Face oedema 64.72 43.91 22 1918 2314 1742527
Cutaneous vasculitis 60.21 43.91 13 1927 237 1744604
Cholestatic liver injury 59.22 43.91 13 1927 257 1744584
Leukopenia 56.98 43.91 29 1911 8451 1736390
Rash erythematous 56.80 43.91 23 1917 3942 1740899
Toxic epidermal necrolysis 56.67 43.91 20 1920 2351 1742490
Aspartate aminotransferase increased 55.93 43.91 31 1909 10725 1734116
Gamma-glutamyltransferase increased 54.44 43.91 24 1916 5074 1739767
Hypersensitivity vasculitis 52.72 43.91 16 1924 1168 1743673
Dermatitis exfoliative 52.41 43.91 17 1923 1544 1743297
Hepatitis acute 51.78 43.91 16 1924 1241 1743600
Hyperthermia 51.08 43.91 17 1923 1674 1743167
Cell death 49.65 43.91 12 1928 367 1744474
Dermatitis bullous 47.98 43.91 15 1925 1209 1743632
Vascular purpura 47.38 43.91 11 1929 282 1744559
Chromaturia 47.19 43.91 18 1922 2632 1742209
Hypersensitivity 45.96 43.91 27 1913 10417 1734424
Angioedema 45.21 43.91 26 1914 9638 1735203
Acute generalised exanthematous pustulosis 45.03 43.91 14 1926 1108 1743733
Hypotension 44.79 43.91 40 1900 29614 1715227
Acute hepatic failure 44.16 43.91 16 1924 2027 1742814

Pharmacologic Action:

SourceCodeDescription
FDA EPC N0000175930 beta Lactamase Inhibitor
FDA MoA N0000000202 beta Lactamase Inhibitors
CHEBI has role CHEBI:36047 antibacterial drug
CHEBI has role CHEBI:35474 anxiolytic drug
MeSH PA D000900 Anti-Bacterial Agents
MeSH PA D000890 Anti-Infective Agents
MeSH PA D065093 beta-Lactamase Inhibitors
MeSH PA D004791 Enzyme Inhibitors

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Septicemia due to Escherichia coli indication 9323009
Bacterial septicemia indication 10001005 DOID:0040085
Infection of skin AND/OR subcutaneous tissue indication 19824006
Staphylococcal pneumonia indication 22754005
Bacterial pneumonia indication 53084003 DOID:874
Klebsiella cystitis indication 60867007
Pneumonia due to Klebsiella pneumoniae indication 64479007
Urinary tract infectious disease indication 68566005
Haemophilus influenzae pneumonia indication 70036007
Infection due to Escherichia coli indication 71057007
Rhinoscleroma indication 72409005 DOID:11336
Acute bacterial sinusitis indication 75498004
Bacterial infection due to Klebsiella pneumoniae indication 186435004
Pneumococcal pneumonia indication 233607000
Escherichia coli urinary tract infection indication 301011002
Bacterial urinary infection indication 312124009
Infective otitis media indication 312218008
Infection due to Staphylococcus aureus indication 406602003
Osteomyelitis due to Staphylococcus aureus indication 428783003
Pneumonia due to Staphylococcus aureus indication 441658007
Sepsis due to Staphylococcus aureus indication 448417001
Sepsis due to Pseudomonas indication 448813005
Bacteroides Endometritis indication
Pneumococcal Acute Otitis Media indication
Haemophilus Parainfluenzae Pneumonia indication
Pseudomonas Aeruginosa Urinary Tract Infection indication
Klebsiella Endometritis indication
Klebsiella Pneumoniae Peritonitis indication
Haemophilus Influenzae Acute Otitis Media indication
Moraxella Catarrhalis Pneumonia indication
Moraxella Catarrhalis Acute Otitis Media indication
Staphylococcus Aureus Joint Infection indication
Staphylococcus Aureus Urinary Tract Infection indication
E. Coli Peritonitis indication
Enterobacter Endometritis indication
Bacteroides Peritonitis indication
Serratia Urinary Tract Infection indication
Citrobacter Urinary Tract Infection indication
Staphylococcus Endometritis indication
E. Coli Endometritis indication
Acute otitis media off-label use 3110003
Pyrexia of unknown origin off-label use 7520000
Chronic purulent otitis media off-label use 38394007 DOID:14247
Cholangitis off-label use 82403002 DOID:9446
Human bite - wound off-label use 262555007
Chancroid off-label use 266143009 DOID:13778
Diverticulitis of gastrointestinal tract off-label use 271366000
Dog bite - wound off-label use 283734005
Cat bite - wound off-label use 283782004
Acute exacerbation of chronic bronchitis off-label use 425748003
Pseudomonas Respiratory Tract Infection in Cystic Fibrosis off-label use
Diabetic Foot Infection off-label use
Obstruction of bile duct contraindication 30144000
Kidney disease contraindication 90708001 DOID:557
Disease of liver contraindication 235856003 DOID:409
Infectious mononucleosis contraindication 271558008 DOID:8568
Pseudomembranous enterocolitis contraindication 397683000

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 3.07 acidic
pKa2 13.53 acidic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
EQ 62.5MG BASE AUGMENTIN XR NEOPHARMA N050785 Sept. 25, 2002 RX TABLET, EXTENDED RELEASE ORAL 6878386 April 4, 2020 MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)
EQ 62.5MG BASE AUGMENTIN XR NEOPHARMA N050785 Sept. 25, 2002 RX TABLET, EXTENDED RELEASE ORAL 7217430 April 4, 2020 MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)
EQ 62.5MG BASE AUGMENTIN XR NEOPHARMA N050785 Sept. 25, 2002 RX TABLET, EXTENDED RELEASE ORAL 7250176 April 4, 2020 MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Beta-lactamase TEM Enzyme INHIBITOR IC50 10.19 WOMBAT-PK CHEMBL
Beta-lactamase GES-13 Enzyme IC50 7 CHEMBL
Beta-lactamase Enzyme IC50 8.05 CHEMBL
Beta-lactamase Enzyme Kd 6.40 CHEMBL
Beta-lactamase Enzyme IC50 8.05 CHEMBL
Carbapenem-hydrolizing beta-lactamase SFC-1 Enzyme IC50 4.14 CHEMBL
Carbepenem-hydrolyzing beta-lactamase KPC Enzyme Ki 4.96 CHEMBL
Beta-lactamase Enzyme IC50 5.07 CHEMBL
Beta-lactamase Enzyme IC50 7.82 CHEMBL
Beta-lactamase Enzyme IC50 8 CHEMBL
Beta-lactamase Enzyme IC50 6.10 CHEMBL
Beta-lactamase Enzyme IC50 5.76 CHEMBL
Beta-lactamase SHV-5 Unclassified Ki 4.60 CHEMBL
Beta-lactamase Enzyme IC50 7.17 CHEMBL
Beta-lactamase SHV-1 Enzyme IC50 6.77 CHEMBL
Beta-lactamase Enzyme IC50 7.07 CHEMBL
Beta-lactamase Enzyme IC50 7.15 CHEMBL
Beta-lactamase Enzyme IC50 4 CHEMBL
Beta-lactamase SHV-1 Enzyme IC50 7.55 CHEMBL
Beta-lactamase OXA-1 Enzyme IC50 5.49 CHEMBL
Beta-lactamase Enzyme IC50 7.70 CHEMBL
Class D beta-lactamase Unclassified IC50 5.70 CHEMBL
Beta-lactamase Enzyme MPC 8.72 WOMBAT-PK

External reference:

IDSource
N0000005804 NUI
C0055860 UMLSCUI
D02370 KEGG_DRUG
23521W1S24 UNII
4948 INN_ID
412318009 SNOMEDCT_US
002808 NDDF
21216 RXNORM
395939008 SNOMEDCT_US
5280980 PUBCHEM_CID
CHEBI:48947 CHEBI
CHEMBL777 ChEMBL_ID
CHEMBL1003 ChEMBL_ID
DB00766 DRUGBANK_ID
61177-45-5 SECONDARY_CAS_RN
J01 PDB_CHEM_ID
L4A PDB_CHEM_ID
D019818 MESH_DESCRIPTOR_UI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2270 TABLET, CHEWABLE 28.50 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2272 TABLET, CHEWABLE 57 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2274 TABLET, FILM COATED 125 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2275 TABLET, FILM COATED 125 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2277 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-2279 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0093-8675 POWDER, FOR SUSPENSION 42.90 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9249 TABLET 125 mg ORAL ANDA 18 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9853 SUSPENSION 42.90 mg ORAL ANDA 16 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9981 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0143-9982 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1619 TABLET, CHEWABLE 28.50 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1643 TABLET, CHEWABLE 57 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1831 TABLET, FILM COATED 125 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1852 TABLET, FILM COATED 125 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-1874 TABLET, FILM COATED 125 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 3 0781-1943 TABLET, MULTILAYER, EXTENDED RELEASE 62.50 mg ORAL ANDA 18 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-6102 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-6104 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 0781-6139 SUSPENSION 42.90 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 10544-931 TABLET, FILM COATED 125 mg ORAL ANDA 18 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 10544-951 TABLET, FILM COATED 125 mg ORAL ANDA 17 sections
AMOXICILLIN AND CLAVULANATE POTASSIUM HUMAN PRESCRIPTION DRUG LABEL 2 16590-019 TABLET, FILM COATED 125 mg ORAL ANDA 14 sections
AMOXICILLIN AND CLAVULANATE POTASSIUM HUMAN PRESCRIPTION DRUG LABEL 2 16590-020 TABLET, FILM COATED 125 mg ORAL ANDA 11 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 16714-292 POWDER, FOR SUSPENSION 28.50 mg ORAL ANDA 19 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 16714-293 POWDER, FOR SUSPENSION 57 mg ORAL ANDA 19 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 16714-294 POWDER, FOR SUSPENSION 42.90 mg ORAL ANDA 17 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 16714-295 TABLET, FILM COATED 125 mg ORAL ANDA 19 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 16714-296 TABLET, FILM COATED 125 mg ORAL ANDA 19 sections
Amoxicillin and Clavulanate Potassium HUMAN PRESCRIPTION DRUG LABEL 2 16714-297 TABLET, FILM COATED 125 mg ORAL ANDA 19 sections