clavulanic acid 🐶 Veterinary Use | 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: -1.06 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: -1.06
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
Bronchiectasis	114.93	21.02	41	4584	11393	56276049
Bone erosion	104.16	21.02	41	4584	14933	56272509
Acute generalised exanthematous pustulosis	75.63	21.02	29	4596	9840	56277602
Hypothyroidism	72.87	21.02	43	4582	38153	56249289
Neutropenia	57.86	21.02	68	4557	158099	56129343
Anaphylactic reaction	55.87	21.02	43	4582	58952	56228490
Drug hypersensitivity	53.29	21.02	87	4538	275118	56012324
Nail dystrophy	48.49	21.02	12	4613	940	56286502
Axillary pain	41.42	21.02	12	4613	1713	56285729
Loss of personal independence in daily activities	40.17	21.02	41	4584	81328	56206114
Hepatitis cholestatic	39.16	21.02	16	4609	6398	56281044
Cholecystitis chronic	38.86	21.02	18	4607	9730	56277712
Appendicitis	37.10	21.02	16	4609	7316	56280126
Jaundice	35.19	21.02	24	4601	27270	56260172
Catheter site haemorrhage	34.82	21.02	12	4613	3006	56284436
Pruritus	33.96	21.02	78	4547	316545	55970897
Cholestasis	30.80	21.02	22	4603	26891	56260551
Toxic skin eruption	29.93	21.02	16	4609	11723	56275719
Hyperleukocytosis	28.65	21.02	7	4618	520	56286922
Red blood cell sedimentation rate abnormal	27.89	21.02	18	4607	18655	56268787
Clostridium difficile colitis	25.40	21.02	17	4608	18721	56268721
Dementia	24.30	21.02	16	4609	17142	56270300
Thrombotic microangiopathy	21.69	21.02	12	4613	9399	56278043

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	85.82	26.26	43	3312	21501	31672488
Spinal muscular atrophy	78.60	26.26	16	3339	395	31693594
Motor neurone disease	74.97	26.26	16	3339	500	31693489
Pneumococcal sepsis	74.78	26.26	18	3337	972	31693017
Stoma closure	66.66	26.26	13	3342	256	31693733
Ischaemic cerebral infarction	66.60	26.26	17	3338	1170	31692819
Lymphadenectomy	62.42	26.26	13	3342	360	31693629
Bronchial disorder	59.68	26.26	16	3339	1333	31692656
Lower respiratory tract infection bacterial	59.27	26.26	13	3342	463	31693526
Increased bronchial secretion	55.17	26.26	16	3339	1778	31692211
Urethral valves	54.01	26.26	11	3344	272	31693717
Cholestasis	52.97	26.26	33	3322	25042	31668947
Sputum increased	52.35	26.26	16	3339	2129	31691860
Disease complication	49.54	26.26	16	3339	2547	31691442
Scoliosis	49.32	26.26	16	3339	2583	31691406
Demyelination	47.31	26.26	16	3339	2939	31691050
Motor dysfunction	45.25	26.26	19	3336	6320	31687669
Resuscitation	45.24	26.26	13	3342	1398	31692591
Respiratory tract infection bacterial	44.75	26.26	13	3342	1453	31692536
Metabolic disorder	42.67	26.26	16	3339	3958	31690031
Chest X-ray abnormal	42.29	26.26	16	3339	4057	31689932
Brain injury	39.97	26.26	17	3338	5833	31688156
Circulatory collapse	39.21	26.26	25	3330	19719	31674270
Anaphylactic shock	38.68	26.26	22	3333	14123	31679866
Lung consolidation	37.71	26.26	16	3339	5457	31688532
Muscle atrophy	37.13	26.26	17	3338	6944	31687045
Intestinal ischaemia	36.94	26.26	17	3338	7028	31686961
Anaphylactic reaction	36.59	26.26	28	3327	29525	31664464
Stevens-Johnson syndrome	34.50	26.26	22	3333	17350	31676639
Hepatitis cholestatic	33.62	26.26	16	3339	7130	31686859
Mechanical ventilation	33.36	26.26	11	3344	1868	31692121
Cerebral ischaemia	33.21	26.26	15	3340	5940	31688049
Secretion discharge	32.58	26.26	14	3341	4923	31689066
Kounis syndrome	32.24	26.26	11	3344	2073	31691916
Meningitis aseptic	31.97	26.26	12	3343	2976	31691013
Endotracheal intubation	28.80	26.26	11	3344	2859	31691130

FDA Adverse Event Reporting System (Geriatric)

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
Anaphylactic reaction	89.22	19.86	67	6824	74907	70846646
Hepatocellular injury	87.61	19.86	55	6836	46036	70875517
Cholestasis	83.23	19.86	54	6837	47818	70873735
Spinal muscular atrophy	78.93	19.86	16	6875	422	70921131
Motor neurone disease	74.10	19.86	16	6875	577	70920976
Acute generalised exanthematous pustulosis	73.78	19.86	34	6857	15363	70906190
Pneumococcal sepsis	69.15	19.86	18	6873	1458	70920095
Stoma closure	67.01	19.86	13	6878	272	70921281
Meningitis aseptic	53.51	19.86	21	6870	6398	70915155
Lower respiratory tract infection bacterial	52.46	19.86	13	6878	864	70920689
Bronchial disorder	52.21	19.86	16	6875	2338	70919215
Ischaemic cerebral infarction	52.19	19.86	16	6875	2341	70919212
Bone erosion	50.14	19.86	26	6865	15147	70906406
Lymphadenectomy	48.80	19.86	13	6878	1151	70920402
Bronchiectasis	48.69	19.86	26	6865	16071	70905482
Hepatitis cholestatic	48.59	19.86	24	6867	12626	70908927
Increased bronchial secretion	47.92	19.86	16	6875	3077	70918476
Nail dystrophy	46.54	19.86	12	6879	936	70920617
Kounis syndrome	46.38	19.86	16	6875	3395	70918158
Jaundice	45.03	19.86	38	6853	50070	70871483
Respiratory tract infection bacterial	43.66	19.86	13	6878	1724	70919829
Sputum increased	43.61	19.86	16	6875	4056	70917497
Anaphylactic shock	43.03	19.86	31	6860	32459	70889094
Stevens-Johnson syndrome	42.47	19.86	32	6859	35875	70885678
Disease complication	42.00	19.86	16	6875	4501	70917052
Resuscitation	39.86	19.86	13	6878	2324	70919229
Axillary pain	38.20	19.86	12	6879	1903	70919650
Demyelination	37.88	19.86	17	6874	7219	70914334
Toxic epidermal necrolysis	37.62	19.86	31	6860	39526	70882027
Brain injury	37.41	19.86	19	6872	10598	70910955
Drug hypersensitivity	37.19	19.86	80	6811	262379	70659174
Clostridium difficile colitis	36.88	19.86	27	6864	28969	70892584
Scoliosis	36.34	19.86	16	6875	6495	70915058
Metabolic disorder	36.16	19.86	17	6874	8023	70913530
Chest X-ray abnormal	34.92	19.86	16	6875	7128	70914425
Pruritus	34.57	19.86	92	6799	345468	70576085
Drug reaction with eosinophilia and systemic symptoms	32.80	19.86	34	6857	57979	70863574
Lung consolidation	32.62	19.86	16	6875	8290	70913263
Intestinal ischaemia	32.36	19.86	18	6873	12046	70909507
Circulatory collapse	32.07	19.86	27	6864	35447	70886106
Muscle atrophy	32.06	19.86	17	6874	10353	70911200
Hypothyroidism	31.77	19.86	30	6861	45725	70875828
Mechanical ventilation	30.85	19.86	11	6880	2570	70918983
Tachypnoea	28.39	19.86	23	6868	28615	70892938
Motor dysfunction	28.39	19.86	17	6874	13053	70908500
Jaundice cholestatic	28.24	19.86	15	6876	9169	70912384
Catheter site haemorrhage	27.38	19.86	12	6879	4819	70916734
Neutropenia	27.25	19.86	70	6821	257086	70664467
Endotracheal intubation	25.29	19.86	11	6880	4335	70917218
Mixed liver injury	24.42	19.86	12	6879	6237	70915316
Bronchospasm	24.08	19.86	19	6872	22773	70898780
Cerebral ischaemia	23.81	19.86	14	6877	10398	70911155
Purpura	23.45	19.86	17	6874	17958	70903595
Liver injury	23.10	19.86	24	6867	41011	70880542
Aspartate aminotransferase increased	23.10	19.86	43	6848	126935	70794618
Appendicitis	22.23	19.86	16	6875	16717	70904836
Secretion discharge	21.02	19.86	14	6877	12919	70908634
Lung infiltration	20.66	19.86	17	6874	21607	70899946
Atelectasis	20.12	19.86	19	6872	28943	70892610
Hepatitis acute	20.05	19.86	14	6877	13948	70907605
Cholangitis	19.98	19.86	13	6878	11536	70910017
Injury	19.97	19.86	28	6863	65217	70856336

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
FDA MoA	N0000000202	beta Lactamase Inhibitors
FDA EPC	N0000175930	beta Lactamase Inhibitor
CHEBI has role	CHEBI:35474	anti-anxiety agents
CHEBI has role	CHEBI:35625	beta-lactamase inhibitors
CHEBI has role	CHEBI:36047	antibacterial drugs
CHEBI has role	CHEBI:33281	antibiotics
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 | Suggest Off label Use Form| |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

🐶 Veterinary Drug Use

Species	Use	Relation
Dogs	Urinary tract infections caused by Escherichia coli	Indication
Dogs	Skin and soft tissue infections caused by beta-lactamase producing Staphylococcus aureus	Indication
Dogs	Skin and soft tissue infections caused by Staphylococcus spp	Indication
Dogs	Skin and soft tissue infections caused by Streptococcus spp	Indication
Dogs	Skin and soft tissue infections caused by Escherichia coli	Indication
Dogs	Skin and soft tissue infections caused by Pasteurella spp	Indication
Cats	Urinary tract infections caused by Escherichia coli	Indication
Cats	Skin and soft tissue infections caused by beta-lactamase producing Staphylococcus aureus	Indication
Cats	Skin and soft tissue infections caused by Staphylococcus spp	Indication
Cats	Skin and soft tissue infections caused by Streptococcus spp	Indication
Cats	Skin and soft tissue infections caused by Escherichia coli	Indication
Cats	Skin and soft tissue infections caused by Pasteurella spp	Indication
Cats	Periodontal infections due aerobic and anaerobic bacteria	Indication

🐶 Veterinary products

Product	Applicant	Ingredients
CLAVAMOX CHEWABLE Tablets, CLAVAMOX tablets	Zoetis Inc.	2
Clavamox Drops	Zoetis Inc.	2
Clavacillin	Dechra Veterinary Products LLC	2
Amoxicillin and Clavulanate Potassium for Oral Suspension	Dechra Veterinary Products LLC	2
Amoxicillin and Clavulanate Potassium Tablets	Cronus Pharma Specialities India Private Limited	2
Amoxicillin and Clavulanate Potassium for Oral Suspension	Cronus Pharma Specialities India Private Limited	2

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)

None

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	Enzyme	AMPC_ECOLI		IC50	7.82	CHEMBL
Beta-lactamase	Enzyme	Q59401_ENTCL		IC50	4	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_ECOLX		IC50	7.55	CHEMBL
Beta-lactamase	Enzyme	AMPC_ENTCL		Kd	6.40	CHEMBL
Beta-lactamase OXA-1	Enzyme	BLO1_ECOLX		IC50	5.49	CHEMBL
Beta-lactamase	Enzyme	AMPC_PSEAE		IC50	6.10	CHEMBL
Beta-lactamase	Enzyme	A4KCT8_9ENTR		IC50	8.05	CHEMBL
Beta-lactamase	Enzyme	A1E3K9_ECOLX		IC50	7.15	CHEMBL
Beta-lactamase	Enzyme	A8RR46_BACCS		IC50	7.07	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	A2RP81_CITFR		IC50	7.17	CHEMBL
Beta-lactamase	Enzyme	Q9EXV5_ECOLX		IC50	8.05	CHEMBL
Beta-lactamase SHV-1	Enzyme	BLA1_KLEPN		IC50	6.77	CHEMBL
Beta-lactamase	Enzyme	Q6GWS8_ECOLX		IC50	5.07	CHEMBL
Beta-lactamase GES-13	Enzyme	D1MIX9_PSEAI		IC50	7	CHEMBL
Beta-lactamase	Enzyme	A0ZX81_KLEPN		IC50	5.76	CHEMBL
Beta-lactamase	Enzyme	Q4TVR4_KLEPN		IC50	7.70	CHEMBL
Class D beta-lactamase	Unclassified	Q50H31_BRAPL		IC50	5.70	CHEMBL
Beta-lactamase	Enzyme	Q2XPY6_SALET		IC50	8	CHEMBL
Beta-lactamase SHV-5	Enzyme	BLA5_KLEPN		Ki	4.60	CHEMBL
Beta-lactamase	Enzyme	D2SSQ3_PSEAI		IC50	7	CHEMBL
Beta-lactamase	Enzyme	Q3SAW3_PSEAI		IC50	7	CHEMBL
Beta-lactamase	Enzyme	BLAC_STAAU		MPC	8.72	WOMBAT-PK
Beta-lactamase	Enzyme	Q670S6_PSELU		IC50	7.44	CHEMBL

External reference:

ID	Source
N0000005804	NUI
D02370	KEGG_DRUG
61177-45-5	SECONDARY_CAS_RN
21216	RXNORM
4018406	VANDF
4019680	VANDF
C0055860	UMLSCUI
CHEBI:48947	CHEBI
J01	PDB_CHEM_ID
CHEMBL777	ChEMBL_ID
DB00766	DRUGBANK_ID
CHEMBL1003	ChEMBL_ID
D019818	MESH_DESCRIPTOR_UI
5280980	PUBCHEM_CID
4948	INN_ID
11128	IUPHAR_LIGAND_ID
23521W1S24	UNII
4463	MMSL
d04405	MMSL
002808	NDDF
002809	NDDF
395938000	SNOMEDCT_US
395939008	SNOMEDCT_US
412318009	SNOMEDCT_US

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	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2270	TABLET, CHEWABLE	28.50 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2272	TABLET, CHEWABLE	57 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2272	TABLET, CHEWABLE	57 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2274	TABLET, FILM COATED	125 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2274	TABLET, FILM COATED	125 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2275	TABLET, FILM COATED	125 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2275	TABLET, FILM COATED	125 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2277	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2277	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2279	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-2279	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8675	POWDER, FOR SUSPENSION	42.90 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0093-8675	POWDER, FOR SUSPENSION	42.90 mg	ORAL	ANDA	26 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9249	TABLET	125 mg	ORAL	ANDA	28 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9853	SUSPENSION	42.90 mg	ORAL	ANDA	32 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9853	SUSPENSION	42.90 mg	ORAL	ANDA	32 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9981	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9981	POWDER, FOR SUSPENSION	28.50 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9982	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0143-9982	POWDER, FOR SUSPENSION	57 mg	ORAL	ANDA	30 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1619	TABLET, CHEWABLE	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1619	TABLET, CHEWABLE	28.50 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1643	TABLET, CHEWABLE	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1643	TABLET, CHEWABLE	57 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1831	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1831	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1852	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1852	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections
Amoxicillin and Clavulanate Potassium	HUMAN PRESCRIPTION DRUG LABEL	2	0781-1874	TABLET, FILM COATED	125 mg	ORAL	ANDA	27 sections