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Gaithersbug
Helium, USP
Veterinary NADA Approved
Overview
Source: Animal Drugs @ FDAProprietary name
Gaithersbug
Active ingredient
Helium, USP
Application type
NADA
Sponsor
AGL Welding Supply Co Inc.
Applications on record
1
First published
August 5, 2024
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 |