Lincomycin Hydrochloride Soluble Powder — veterinary medication

Overview

Source: Animal Drugs @ FDA

Proprietary name

Lincomycin Hydrochloride Soluble Powder

Active ingredient

Lincomycin Hydrochloride

Application type

ANADA

Sponsor

Huvepharma EOOD

Applications on record

2

First published

January 3, 2017

Applications

Source: Animal Drugs @ FDA

Every Green Book application recorded for this proprietary name.
Application no.	Type	Status	Withdrawn
200189	ANADA	Approved	—
200303	ANADA	Approved	—

Adverse event reports

Source: openFDA VeDDRA

135

Reports mentioning this ingredient

December 30, 1987 – September 2, 2024

10

Classified serious

per reporter assessment

37

Lack of expected efficacy

resistance signal

7

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 “LINCOMYCIN HYDROCHLORIDE”. 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
Lack of efficacy (bacteria) - NOS	28
Death	25
Diarrhoea	12
Vomiting	8
Lack of efficacy - NOS	8
Depression	8
Accidental exposure	7
Ataxia	5
Thrombocytopenia	4
Anorexia	4
Fever	4
Skin hyperaemia	4
Pruritus	4
Unclassifiable adverse event	4
Vials, Leaking	4
Bloody diarrhoea	4
Product Defect, General	4
Abdominal pain	3
Polydipsia	3
Deafness	3

Species affected

Source: openFDA VeDDRA

Pig 49 Dog 33 Cat 13 Human 5 Cattle 3 Sheep 2 Horse 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