Marbofloxacin Chewable Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Marbofloxacin Chewable Tablets

Active ingredient

Marbofloxacin

Application type

ANADA

Sponsor

Felix Pharmaceuticals Pvt. Ltd.

Applications on record

1

First published

February 1, 2023

Adverse event reports

Source: openFDA VeDDRA

1,828

Reports mentioning this ingredient

September 10, 1999 – March 6, 2026

375

Classified serious

per reporter assessment

337

Lack of expected efficacy

resistance signal

18

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 “MARBOFLOXACIN”. 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
Vomiting	221
Anorexia	189
Lack of efficacy (bacteria) - NOS	188
Depression	139
Death by euthanasia	96
Ataxia	94
Death	93
Lethargy (see also Central nervous system depression in 'Neurological')	78
Anaemia NOS	73
Convulsion	71
Diarrhoea	71
Elevated alanine aminotransferase (ALT)	67
Blindness	65
Lameness	61
Elevated serum alkaline phosphatase (SAP)	60
Leucocytosis NOS	60
Weight loss	59
Elevated blood urea nitrogen (BUN)	51
Fever	48
Elevated creatinine	44

Species affected

Source: openFDA VeDDRA

Dog 1,215 Cat 558 Human 6 Other 3 Parrot 1 Rabbit 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