Legacy Sterile Solution Gentamicin Sulfate Solution — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Legacy Sterile Solution Gentamicin Sulfate Solution

Active ingredient

Gentamicin Sulfate

Application type

ANADA

Sponsor

Huvepharma EOOD

Applications on record

1

First published

July 2, 2018

Adverse event reports

Source: openFDA VeDDRA

1,176

Reports mentioning this ingredient

January 3, 1987 – March 25, 2026

372

Classified serious

per reporter assessment

98

Lack of expected efficacy

resistance signal

9

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 “GENTAMICIN SULFATE”. 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
Loss of hearing	217
Product defect, product difficult to use/handle (see also 'Drug device difficult to use/handle')	157
Difficulty of Use	138
Administration device NOS, priming issue	126
Dispenser, Abnormal	118
Product Defect, General	76
Administration device NOS, abnormal	74
Administration device NOS, malfunction	68
Lack of efficacy - NOS	51
Appearance, Abnormal	40
Containers, Leaking	30
Containers, Damaged	27
Death	24
Deafness	19
Underfilling, Container	18
Vomiting	17
Abdominal pain	16
Shaking	15
Product problem	15
Lethargy (see also Central nervous system depression in Neurological)	15

Species affected

Source: openFDA VeDDRA

Dog 497 Horse 76 Cat 30 Cattle 4 Pig 4 Human 3 Rat 2 Parrot 1 Other 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