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

Stem definition	Drug id	CAS RN
beta-lactamase inhibitors	669	58001-44-8

Description:

Molecule	Description
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

Molecule

Description

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:

Property	Value	Reference
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 µM/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:

Date	Agency	Company	Orphan
Aug. 6, 1984	FDA	DR REDDYS LABS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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 term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients 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:

Source	Code	Description
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)

Disease	Relation	SNOMED_ID	DOID
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 level	Dissociation constant	Type (acidic/basic)
pKa1	3.07	acidic
pKa2	13.53	acidic

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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:

Target	Class	UniProt	Action	Type	Activity value (-log[M])	Bioact source	MoA source
Beta-lactamase TEM	Enzyme	BLAT_ECOLX	INHIBITOR	IC50	10.19	WOMBAT-PK	CHEMBL
Beta-lactamase GES-13	Enzyme	D1MIX9_PSEAI		IC50	7	CHEMBL
Beta-lactamase	Enzyme	A4KCT8_9ENTR		IC50	8.05	CHEMBL
Beta-lactamase	Enzyme	AMPC_ENTCL		Kd	6.40	CHEMBL
Beta-lactamase	Enzyme	Q9EXV5_ECOLX		IC50	8.05	CHEMBL
Carbapenem-hydrolizing beta-lactamase SFC-1	Enzyme	Q6JP75_SERFO		IC50	4.14	CHEMBL
Carbepenem-hydrolyzing beta-lactamase KPC	Enzyme	BLKPC_KLEPN		Ki	4.96	CHEMBL
Beta-lactamase	Enzyme	Q6GWS8_ECOLX		IC50	5.07	CHEMBL
Beta-lactamase	Enzyme	AMPC_ECOLI		IC50	7.82	CHEMBL
Beta-lactamase	Enzyme	Q2XPY6_SALET		IC50	8	CHEMBL
Beta-lactamase	Enzyme	AMPC_PSEAE		IC50	6.10	CHEMBL
Beta-lactamase	Enzyme	A0ZX81_KLEPN		IC50	5.76	CHEMBL
Beta-lactamase SHV-5	Unclassified	BLA5_KLEPN		Ki	4.60	CHEMBL
Beta-lactamase	Enzyme	A2RP81_CITFR		IC50	7.17	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_KLEPN		IC50	6.77	CHEMBL
Beta-lactamase	Enzyme	A8RR46_BACCS		IC50	7.07	CHEMBL
Beta-lactamase	Enzyme	A1E3K9_ECOLX		IC50	7.15	CHEMBL
Beta-lactamase	Enzyme	Q59401_ENTCL		IC50	4	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_ECOLX		IC50	7.55	CHEMBL
Beta-lactamase OXA-1	Enzyme	BLO1_ECOLX		IC50	5.49	CHEMBL
Beta-lactamase	Enzyme	Q4TVR4_KLEPN		IC50	7.70	CHEMBL
Class D beta-lactamase	Unclassified	Q50H31_BRAPL		IC50	5.70	CHEMBL
Beta-lactamase	Enzyme	BLAC_STAAU		MPC	8.72	WOMBAT-PK

External reference:

ID	Source
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:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
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