Acepromazine Maleate Tablets — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Acepromazine Maleate Tablets

Active ingredient

Acepromazine Maleate

Application type

NADA

Sponsor

Bolar Pharmaceutical Co., Inc.

Applications on record

2

First published

June 1, 2016

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
135299	NADA	Withdrawn	—
200757	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

1,408

Reports mentioning this ingredient

April 22, 1987 – March 24, 2026

492

Classified serious

per reporter assessment

117

Lack of expected efficacy

resistance signal

14

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 “ACEPROMAZINE MALEATE”. 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
Death	141
Sedation prolonged	49
Cardiac arrest	44
Depression	42
Vomiting	38
Apnoea	37
Recovery prolonged	31
Ataxia	31
Death by euthanasia	30
Anorexia	30
Sedation	26
Convulsion	25
Elevated blood urea nitrogen (BUN)	23
Bradycardia	22
INEFFECTIVE, SEDATION	21
Fever	21
INEFFECTIVE, TRANQUILIZATION	21
Collapse (see also 'Cardio-vascular' and 'Systemic disorders')	19
Pale mucous membrane	18
Dyspnoea	18

Species affected

Source: openFDA VeDDRA

Dog 914 Cat 318 Horse 55 Human 8 Other 7 Cattle 6 Rabbit 4 Mouse 4 Pig 3 Other Rodents 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.

New Animal Drug Application (NADA). A pioneer approval evaluated for target animal safety, therapeutic effectiveness, manufacturing controls and — for food-producing species — human food safety including residue depletion.

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