Maropitant Citrate Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Maropitant Citrate Tablets

Active ingredient

Maropitant

Application type

ANADA

Sponsor

Felix Pharmaceuticals Pvt. Ltd.

Applications on record

2

First published

July 1, 2024

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200785	ANADA	Approved	—
200833	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

3,221

Reports mentioning this ingredient

May 29, 2007 – March 23, 2026

646

Classified serious

per reporter assessment

140

Lack of expected efficacy

resistance signal

55

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 “MAROPITANT”. 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
INEFFECTIVE, ANTIEMETIC	350
Depression	274
Injection site pain	270
Anorexia	254
Death	236
Death by euthanasia	180
Hypersalivation	163
Vomiting	149
Ataxia	129
Abnormal radiograph finding	117
Anaphylaxis	105
Elevated serum alkaline phosphatase (SAP)	104
Elevated alanine aminotransferase (ALT)	96
Diarrhoea	95
Convulsion	95
Trembling	84
Facial oedema	84
Digestive tract hypomotility	84
Anaemia NOS	81
Elevated total bilirubin	78

Species affected

Source: openFDA VeDDRA

Dog 2,559 Cat 502 Human 35 Other 3 Mouse 2 Rabbit 2

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