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This document provides information regarding the combined use of ractopamine hydrochloride and tylosin phosphate for improved growth and health in finishing swine, including indications for use, dosage,

How to fill out dom of information summary

How to fill out Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172

1. Obtain the Freedom of Information Summary (FOIS) form from the FDA website.
2. Fill out Section 1 with the application number, NADA 141-172.
3. In Section 2, provide the introduction that outlines the drug’s purpose and target species.
4. Complete Section 3 by detailing the formulation of the drug, including active ingredients and concentrations.
5. In Section 4, summarize the pharmacological and toxicological information provided in the original application.
6. Fill out Section 5 with the results of the effectiveness studies conducted.
7. Include Section 6 which details the safety data presented in the application, including any adverse event reporting.
8. Review all sections for completeness and accuracy.
9. Submit the FOIS along with the Supplemental New Animal Drug Application.

Who needs Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172?

1. Individuals or organizations submitting a Supplemental New Animal Drug Application associated with NADA 141-172.
2. Veterinarians and animal health professionals looking to access information regarding the approved drug.
3. Regulatory professionals needing to comply with FDA reporting and transparency requirements.

People Also Ask about

What is an approved new drug application?

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

What is abbreviated new animal drug application?

The Abbreviated New Animal Drug Application (ANADA) process is for the approval of generic copies of new animal drug products that have been previously approved and shown to be safe and effective.

What is the animal drug User fee Act?

The ADUFA, originally signed into law in 2003 and reauthorized in 2008, 2013, 2018 and 2023 authorizes the FDA to collect fees for certain animal drug applications and supplements, products, establishments, and sponsors of animal drug applications and/or investigational animal drug submissions.

What is a nada number?

Look at the drug's label. All FDA-approved animal drugs have a New Animal Drug Application (NADA) number, or for generic animal drugs, an Abbreviated New Animal Drug Application (ANADA) number.

What is approved by the FDA under Nada?

NADA - A NADA is used to seek approval of a new animal drug. ANADA - An ANADA is used to seek approval of a generic new animal drug. A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration.

What is the FOI summary?

A Freedom of Information (FOI) Summary provides the public with the key information that FDA used to determine that a New Animal Drug Application (NADA), an Abbreviated New Animal Drug Application (ANADA), or a Conditional New Animal Drug Application (CNADA) met the requirements for approval or conditional approval.

What is abbreviated new animal drug application Anda?

The Abbreviated New Animal Drug Application (ANADA) process is for the approval of generic copies of new animal drug products that have been previously approved and shown to be safe and effective.

What is a nada new animal drug application?

NADA - A NADA is used to seek approval of a new animal drug. ANADA - An ANADA is used to seek approval of a generic new animal drug. A generic new animal drug is a copy of an approved new animal drug for which patents or other periods of exclusivity are near expiration.

For pdfFiller’s FAQs

What is Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172?

The Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172 is a document that provides a summary of the information submitted to the FDA regarding a supplemental application for an animal drug, which includes the drug's safety, effectiveness, manufacturing, and labeling.

Who is required to file Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172?

The sponsor of the drug, typically a pharmaceutical company or entity that produces the animal drug, is required to file the Freedom of Information Summary as part of the supplemental new animal drug application process.

How to fill out Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172?

To fill out the Freedom of Information Summary, the applicant must provide relevant details about the drug, including the drug's name, application number, summaries of safety and effectiveness data, and any changes being made or proposed in the supplemental application.

What is the purpose of Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172?

The purpose of the Freedom of Information Summary is to inform the public about the details of the supplemental application for the animal drug, including the rationale behind the application and its potential impact on animal health and safety.

What information must be reported on Freedom of Information Summary - Supplemental New Animal Drug Application NADA 141-172?

The information that must be reported includes the product name, the application number, a summary of the supplemental changes, safety and effectiveness information, labeling revisions, and any other relevant data that supports the application.