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  • Aviax (semduramicin Sodium) Plus Stafac (virginiamycin). Foi Summary - Fda

Get Aviax (semduramicin Sodium) Plus Stafac (virginiamycin). Foi Summary - Fda

Approval Date: April 6, 2005 AMENDED FREEDOM OF INFORMATION SUMMARY ORIGINAL NEW ANIMAL DRUG APPLICATION NADA 141-226 AVIAX (Semduramicin sodium) plus STAFAC (Virginiamycin) plus ROXARSONE (Roxarsone).

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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.

  1. 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.
  2. 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'.
  3. Complete the established name section, listing 'Semduramicin sodium', 'Virginiamycin', and 'Roxarsone' as active ingredients.
  4. Provide the proprietary names for each ingredient as 'AVIAX', 'STAFAC', and 'ROXARSONE'.
  5. Indicate the dosage form as 'Type A medicated article' and specify how it is supplied, which is in '50 lb bags'.
  6. 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'.
  7. Complete the route of administration by writing 'Oral, via feed' and identify the species/class as 'Broiler chickens'.
  8. 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.'.
  9. Fill in the pharmacological category which includes 'anticoccidial', 'antimicrobial', and 'growth promotant' for the respective ingredients.
  10. Review the effectiveness, safety, and human safety sections thoroughly to ensure compliance and agreement with regulatory standards outlined for animal drug combinations.
  11. 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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Questions & Answers

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Yes, patients can directly report any adverse events they experience with AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) to MedWatch. This empowers patients to contribute to the safety monitoring of medications. Encouraging patients to report these occurrences helps ensure comprehensive safety evaluations, benefiting everyone.

After you submit a MedWatch report, the FDA will review the information and take appropriate actions as needed. This may include further investigation into the AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) products related to the report. Additionally, the information may contribute to ongoing safety assessments, ultimately enhancing patient care.

Submitting a MedWatch report is straightforward. You can report online via the FDA's MedWatch website, by fax, or through traditional mail. Be sure to include all relevant details about the AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) and the adverse event to ensure proper evaluation by the FDA.

You should submit a Medical Device Reporting (MDR) when you observe an adverse event related to the use of a medical device involving AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin). This submission is necessary if the event results in serious injury, illness, or death. Timely reporting helps the FDA monitor safety and implement any necessary actions to protect public health.

To file a MedWatch report, you need relevant patient information, product details including the specific AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) used, and information about the adverse event. Additionally, include the reporting healthcare professional's contact information, and any other pertinent medical history. This information ensures that the FDA can effectively assess the safety and efficacy of the medication.

Yes, the FDA is responsible for approving veterinary medicine, ensuring that products are safe and effective for animal use. This includes medications like AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin). Understanding the FDA's role can provide reassurance that the veterinary products you use have undergone rigorous testing and evaluation.

To check if a product has FDA approval, you can visit the FDA's official website and search their database of approved drugs. This search will help you find important information about products like AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin). Checking for FDA approval is a critical step in ensuring the safety and efficacy of veterinary products.

Avilamycin is commonly used in poultry for its antimicrobial properties, which help in improving feed efficiency and growth performance. Products like AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin) often complement the role of avilamycin in promoting better health among birds. Utilizing these products can lead to healthier poultry and improved production outcomes.

All FDA-approved veterinary drugs can be found in the FDA's Animal Drug Approval database. This database is a valuable resource for anyone looking to verify the approval status of products like AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin). You can search for specific drugs to ensure you have the most accurate information available.

Yes, the FDA maintains a comprehensive list of all approved drugs on their official website. This list includes key details about medications like AVIAX (Semduramicin Sodium) Plus STAFAC (Virginiamycin). If you want up-to-date information on drug approvals, visiting the FDA's site is the best approach.

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© Copyright 1997-2025
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
Privacy Notice
Legal Hub
Content Takedown Policy
Bug Bounty Program
About Us
Blog
Affiliates
Contact Us
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate WorkFlow
DocHub
Instapage
Social Media
Call us now toll free:
+1 833 426 79 33
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232