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Get Freedom Of Information Summary Anada 200-313 ... - Fda
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How to fill out the FREEDOM OF INFORMATION SUMMARY ANADA 200-313 online
This guide provides clear and concise instructions on how to accurately complete the FREEDOM OF INFORMATION SUMMARY ANADA 200-313 form online. Following these steps will ensure that your submission is complete and complies with the necessary requirements.
Follow the steps to effectively complete the FREEDOM OF INFORMATION SUMMARY ANADA 200-313 form online.
- Press the ‘Get Form’ button to access the FREEDOM OF INFORMATION SUMMARY ANADA 200-313 form. Ensure that you have a reliable internet connection to facilitate downloading the document.
- In the 'General Information' section, provide the sponsoring company's details, including the name (Phoenix Scientific, Inc.) and address (3915 South 48th Street Terrace, St. Joseph, MO 64503).
- Under 'Established Name,' fill in 'Levamisole Hydrochloride'. In the 'Trade Name/Proprietary Name,' enter 'Levamisole Hydrochloride Soluble Pig Wormer.'
- For 'Dosage Form,' specify 'Soluble Powder.' Indicate how it is supplied, noting that it comes in a 500 mL graduated HDPE bottle containing 20.17 grams of levamisole hydrochloride.
- Describe how the product is dispensed, filling in 'OTC' in the relevant field.
- List the amount of active ingredients under the respective section, confirming the content of 18.15 grams of levamisole hydrochloride activity.
- In the 'Species' section, indicate 'Swine.' Provide the labeled dosage and indications, referencing the attached labeling for additional details on mixing instructions.
- For 'Target Animal Safety and Drug Effectiveness,' summarize the waiver granted for not conducting an in vivo bioequivalence study and the data relied upon from the pioneer product.
- Complete the 'Human Food Safety' section, detailing tolerances and withdrawal times, and reiterate the regulatory method for residues.
- In the final section, provide agency conclusions that affirm the product's safety and efficacy, and ensure that all attachments are included.
- Once all fields are filled, save your changes. You can then download, print, or share the filled form as necessary.
Start completing your FREEDOM OF INFORMATION SUMMARY ANADA 200-313 form online to ensure a smooth submission process.
Once a new drug application is filed, an FDA review team--medical doctors, chemists, statisticians, microbiologists, pharmacologists, and other experts--evaluates whether the studies the sponsor submitted show that the drug is safe and effective for its proposed use.
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