TulajectTM 100 — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

TulajectTM 100

Active ingredient

Tulathromycin

Application type

ANADA

Sponsor

Cronus Pharma Specialities India Private Ltd.

Applications on record

1

First published

October 1, 2024

Adverse event reports

Source: openFDA VeDDRA

3,104

Reports mentioning this ingredient

January 4, 2005 – March 23, 2026

1,602

Classified serious

per reporter assessment

1,764

Lack of expected efficacy

resistance signal

166

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 “TULATHROMYCIN”. 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	909
Lack of efficacy (bacteria) - NOS	882
Lack of efficacy - NOS	636
DEATH-TREATMENT FAILURE	259
Unclassifiable adverse event	207
Injection site pain	171
Accidental exposure	163
Injection site swelling	109
Necropsy performed	107
PR-LUNG(S), LESION(S)	93
Injection site reaction NOS	93
No sign	85
Containers, Abnormal	81
CULTURE/TITER DATA ABNORMAL	76
Death by euthanasia	61
Color, Abnormal	56
Containers, Damaged	52
Unrelated death	52
Other abnormal test result NOS	48
Vials, Damaged	45

Species affected

Source: openFDA VeDDRA

Cattle 2,220 Human 340 Pig 78 Goat 29 Sheep 18 Dog 17 Cat 13 Other Deer 7 Horse 7 Alpaca 3 White tailed deer 2 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