Get Aviax (semduramicin Sodium) Plus Stafac (virginiamycin). Foi Summary - Fda
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How to fill out the AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) FOI Summary - FDA online
This guide provides a detailed and user-friendly approach to completing the AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) FOI Summary. It is designed to assist users at all experience levels in understanding and filling out this important document correctly and efficiently.
Follow the steps to effectively fill out the AVIAX and STAFAC FOI summary form.
- Press the ‘Get Form’ button to access the form and open it in the editing interface, allowing you to start filling out the required information.
- In the general information section, fill in the file number as 'NADA 141-226' and provide the name of the sponsor, which is 'Phibro Animal Health' along with their address '710 Rt. 46 East, Suite 401, Fairfield, NJ 07004'.
- Complete the established name section, listing 'Semduramicin sodium', 'Virginiamycin', and 'Roxarsone' as active ingredients.
- Provide the proprietary names for each ingredient as 'AVIAX', 'STAFAC', and 'ROXARSONE'.
- Indicate the dosage form as 'Type A medicated article' and specify how it is supplied, which is in '50 lb bags'.
- For the amount of active ingredient, specify 'Semduramicin sodium: 22.7 grams per lb', 'Virginiamycin: 5, 10, 20, 50, and 227 grams per lb', and 'Roxarsone: 10, 20, and 50 percent'.
- Complete the route of administration by writing 'Oral, via feed' and identify the species/class as 'Broiler chickens'.
- In the recommended dosage section, state 'Semduramicin sodium at 22.7 grams per ton plus virginiamycin at 20 grams per ton plus roxarsone at 22.7 to 45.4 grams per ton. Feed continuously as sole ration throughout growth period.'.
- Fill in the pharmacological category which includes 'anticoccidial', 'antimicrobial', and 'growth promotant' for the respective ingredients.
- Review the effectiveness, safety, and human safety sections thoroughly to ensure compliance and agreement with regulatory standards outlined for animal drug combinations.
- After completing all required fields and verifying the accuracy of the information, save your changes and utilize the options to download, print, or share the completed form as needed.
Complete your documents online today for the AVIAX and STAFAC FOI Summary to ensure compliance and successful submission.
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