Enrofloxacin Flavored Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Enrofloxacin Flavored Tablets

Active ingredient

Enrofloxacin

Application type

ANADA

Sponsor

Dechra Veterinary Products LLC

Applications on record

3

First published

June 1, 2016

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200551	ANADA	Approved	—
200680	ANADA	Approved	—
200810	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

8,412

Reports mentioning this ingredient

December 27, 1989 – March 25, 2026

3,101

Classified serious

per reporter assessment

582

Lack of expected efficacy

resistance signal

268

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 “ENROFLOXACIN”. 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
Solution, Abnormal	950
Vomiting	542
Uncoded sign	502
Mydriasis	484
Blindness	469
Solution/Suspension, crystals	437
Death	393
Anorexia	317
Retinal disorder NOS	291
Death by euthanasia	280
Ataxia	271
Accidental exposure	263
Lethargy (see also Central nervous system depression in 'Neurological')	259
Behavioural disorder NOS	209
Seizure NOS	203
Convulsion	198
Depression	175
Unclassifiable adverse event	174
Diarrhoea	170
Impaired vision	145

Species affected

Source: openFDA VeDDRA

Dog 3,707 Cat 1,594 Human 276 Cattle 232 Horse 73 Pig 53 Rabbit 41 Other Birds 16 Other 14 Guinea Pig 13 Chicken 9 Mouse 7

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