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Public Master Files (PMFs) in development

https://www.fda.gov/animal-veterinary/minor-useminor-species/public-master-files-pmfs-development

… Human Food Safety Environmental Impact 003-883 Ivermectin/ Solution /Injection Treatment and control of … Minor Use Animal Drug Program 11/18/1991 005-421 Ivermectin/ Solution/ Injection Control of ear mites … 12/05/1996 12/05/1996 12/05/1996 4 12/05/1996 005-484 Ivermectin/ Solution/ Topical Treatment and control of the …

Public Master Files (PMFs) supporting approved New Animal Drug Applications (NADAs)

https://www.fda.gov/animal-veterinary/minor-useminor-species/public-master-files-pmfs-supporting-approved-new-animal-drug-applications-nadas

… Animal Drug Program NADA FOI 012-350 NADA 012-350 003-895 Ivermectin/ Solution/ Injection Treatment and control of … Animal Drug Program NADA FOI 125-933 NADA 125-933 005-059 Ivermectin/Solution / Injection Treatment and control of … Animal Drug Program NADA FOI 039-417 NADA 039-417 005-307 Ivermectin/ Solution/ Injection Treatment and control of ear …

Internet Pharmacy Warning Letters

https://www.fda.gov/drugs/drug-supply-chain-integrity/internet-pharmacy-warning-letters

Coronavirus Disease 2019 (COVID-19)

https://www.fda.gov/emergency-preparedness-and-response/public-health-preparedness-and-response/coronavirus-disease-2019-covid-19

… Press Release / Public Statement Biologics 04/05/2024 Ivermectin and COVID-19 There continues to be interest in a drug called ivermectin for the prevention or treatment of COVID-19 in humans. The FDA has not authorized or approved ivermectin for use in preventing or treating COVID-19 in …

Bulk Drug Substances Reviewed and Not Listed

https://www.fda.gov/animal-veterinary/animal-drug-compounding/bulk-drug-substances-reviewed-and-not-listed

… for use in horses as part of a combination product with ivermectin (NADA 141-214 and NADA 141-215) and with …

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