Get the free Freedom of Information Summary Original New Animal Drug Application NADA 141-090 - fda

This document provides a summary of the approval for the combined use of Diclazuril and Virginiamycin in broiler chicken feeds for the prevention of coccidiosis and improvement of feed efficiency.

How to fill out dom of information summary

How to fill out Freedom of Information Summary Original New Animal Drug Application NADA 141-090

1. Begin by gathering all necessary information about the drug and its application.
2. Fill out the application form with accurate details regarding the drug's name, purpose, and manufacturing process.
3. Include information about the intended use, dosage, and administration of the drug.
4. Provide data from preclinical and clinical studies conducted to demonstrate safety and effectiveness.
5. Attach any relevant labeling and packaging information to ensure compliance with regulations.
6. Submit the completed application along with the required fees and additional documents as specified in the guidelines.

Who needs Freedom of Information Summary Original New Animal Drug Application NADA 141-090?

1. Veterinary pharmaceutical companies seeking approval for new animal drugs.
2. Regulatory bodies assessing the safety and efficacy of new animal drug applications.
3. Researchers and practitioners in the veterinary field looking for information on new treatments.

People Also Ask about

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.

Are veterinary drugs FDA approved?

A acepromazine – sedative, tranquilizer, and antiemetic. afoxolaner - antiparasitic. albendazole - anthelminthic. alphaxolone - hypnotic/sedative. alprazolam – benzodiazepine used as an anxiolytic and tranquilizer. altrenogest – used to synchronizes estrus. amantadine – analgesic for chronic pain.

What is one of the most recent approvals for an animal drug?

Drug Approval Information DateApplication NumberProduct Name September 19, 2024 NADA 141-585 Zenrelia (ilunocitinib tablets) September 10, 2024 ANADA 200-774 Tulaject 25 (tulathromycin injection) September 5, 2024 ANADA 200-773 Tulaject 100 (tulathromycin injection) September 5, 2024 ANADA 200-795 CARPROFEN Soft Chewable Tablets18 more rows

What is the Orange Book of drugs?

The Orange Book is composed of four parts: (1) approved prescription drug products with therapeutic equivalence evaluations (Prescription Drug Product List); (2) approved Over-the-Counter (OTC) drug products (OTC Drug Product List); (3) Drug Products with Approval under Section 505 of the FD&C Act administered by the

What is the green book in pharmaceutical regulatory science?

The United States Food and Drug Administration (US FDA) established, published, and maintains the “Green Book” which is a list of approved animal products. The list is publicly available, maintained every month and serves as a searchable database for animal product organizations and public.

What is the Green Book report in the animal drugs?

Green Book Reports The Green Book is a list of most FDA-approved and conditionally approved animal drugs and includes information about patents and marketing exclusivity.

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.

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What is Freedom of Information Summary Original New Animal Drug Application NADA 141-090?

The Freedom of Information Summary Original New Animal Drug Application NADA 141-090 is a document that summarizes the safety and effectiveness data submitted to the FDA for a new animal drug application. It provides insight into the evaluation process and the final decision on the approval of the drug.

Who is required to file Freedom of Information Summary Original New Animal Drug Application NADA 141-090?

The applicant, typically a pharmaceutical company or a sponsor of the new animal drug, is required to file the Freedom of Information Summary Original New Animal Drug Application NADA 141-090 as part of their submission to the FDA.

How to fill out Freedom of Information Summary Original New Animal Drug Application NADA 141-090?

To fill out the Freedom of Information Summary Original New Animal Drug Application NADA 141-090, the applicant must provide detailed information including the drug's formulation, proposed uses, labeling, manufacturing processes, and safety and efficacy data, according to the specific guidelines provided by the FDA.

What is the purpose of Freedom of Information Summary Original New Animal Drug Application NADA 141-090?

The purpose of the Freedom of Information Summary Original New Animal Drug Application NADA 141-090 is to make information about new animal drugs available to the public, ensuring transparency in the approval process and allowing stakeholders to review the data that supports the drug's safety and efficacy.

What information must be reported on Freedom of Information Summary Original New Animal Drug Application NADA 141-090?

The information that must be reported on the Freedom of Information Summary Original New Animal Drug Application NADA 141-090 includes the drug's active ingredient, indications for use, dosage, administration guidelines, safety data, effectiveness studies, and any adverse event information related to the drug.