Amoxicillin and Clavulanate Potassium for Oral Suspension

Overview

Source: Animal Drugs @ FDA

Proprietary name

Amoxicillin and Clavulanate Potassium for Oral Suspension

Active ingredient

Amoxicillin Trihydrate Clavulanate Potassium

Application type

ANADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

April 10, 2024

Adverse event reports

Source: openFDA VeDDRA

6,057

Reports mentioning this ingredient

March 23, 1987 – November 12, 2024

10

Classified serious

per reporter assessment

531

Lack of expected efficacy

resistance signal

65

Human operator exposure

needle-stick or splash

Not a risk measure. Veterinary adverse event reports are influenced by how many animals are treated, reporting practice and product age. Reports do not establish that the product caused the event, and a single report can cover an entire herd or flock. Attribution here is by active ingredient because the source dataset redacts brand names.

Attributed by active ingredient “AMOXICILLIN, CLAVULANATE”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Reported reactions

Source: openFDA VeDDRA

Clinical signs coded in the VICH VeDDRA four-level hierarchy, most frequent first.

Reaction terms reported for this ingredient, by report count.
Reaction (VeDDRA term)	Reports	Relative frequency
Color, Abnormal	2,478
Suspension, Abnormal	1,417
Vomiting	740
Lack of efficacy (bacteria) - NOS	503
Anorexia	501
Depression	440
Death	276
Underfilling, Package	253
Diarrhoea	249
Seal, Abnormal	240
Elevated alanine aminotransferase (ALT)	183
Elevated serum alkaline phosphatase (SAP)	177
Death by euthanasia	175
Anaemia NOS	159
Ataxia	158
Convulsion	150
Fever	146
Granules/Powder, Abnormal	146
No sign	130
Elevated blood urea nitrogen (BUN)	127

Species affected

Source: openFDA VeDDRA

Dog 1,833 Cat 1,097 Human 35 Other 13 Rabbit 7 Ferret 2 Parrot 1 Other Birds 1 Monkey 1 Bobcat 1 Rat 1

Regulatory context

Abbreviated New Animal Drug Application (ANADA). A generic animal drug demonstrating bioequivalence, pharmaceutical equivalence and identical manufacturing criteria to the pioneer application. Veterinary generics have no formal therapeutic-equivalence coding system; they match the pioneer NADA specification instead.

Extra-label use in food-producing animals is governed by the Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) and 21 CFR Part 530. It requires a valid veterinarian-client-patient relationship and is prohibited outright for certain drug classes. Withdrawal times are determined by FARAD, not by this index.

Sources for this page

Animal Drugs @ FDA	FDA CVM	Applications, sponsor, status, withdrawal
Animal & Veterinary Events	FDA CVM	VeDDRA adverse event aggregates by active ingredient