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N/A

Nitrous Oxide, USP

Veterinary NADA Approved 32 adverse event reports

Overview

Source: Animal Drugs @ FDA
Proprietary name
N/A
Active ingredient
Nitrous Oxide, USP
Application type
NADA
Sponsor
Matheson Tri-Gas, Inc.
Applications on record
1
First published
August 5, 2024

Adverse event reports

Source: openFDA VeDDRA
32
Reports mentioning this ingredient
October 8, 2012 – March 10, 2022
11
Classified serious
per reporter assessment
2
Lack of expected efficacy
resistance signal
0
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 “N/A”. Green Book ingredient names and VeDDRA ingredient names do not always agree exactly, so attribution is approximate and labelled as such.

Species affected

Source: openFDA VeDDRA
Dog 30 Cat 2

Regulatory context

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