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  • Nada 140-890. Foi Summary - Fda

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FREEDOM OF INFORMATION SUMMARY EXCENEL Sterile Suspension (ceftiofur hydrochloride) for the treatment/control of swine bacterial respiratory disease (swine bacterial pneumonia) associated with Actinobacillus.

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Drugs are tested on people to make sure they are safe and effective. FDA review teams thoroughly examine all of the submitted data related to the drug or device and make a decision to approve or not to approve it. FDA monitors all drug and device safety once products are available for use by the public.

The Green Book is a list of most FDA-approved animal drugs and includes information about patents and marketing exclusivity. For more information about the Green Book, see Approved Animal Drug Products (Green Book).

Animal Drugs– The Federal Food, Drug, and Cosmetic Act gives FDA the legal authority to approve and regulate drugs for animals. Before a drug company can market an animal drug, the company must get the drug approved by FDA.

A Freedom of Information (FOI) Summary describes the safety and effectiveness information submitted by the drug company to FDA to support the approval of a New Animal Drug Application (NADA) or Abbreviated New Animal Drug Application (ANADA).

FDA Approval: What it means. FDA approval of a drug means that data on the drug's effects have been reviewed by CDER, and the drug is determined to provide benefits that outweigh its known and potential risks for the intended population.

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. Many drug manufacturers currently list the six-digit NADA or ANADA number and the statement, “Approved by FDA,” on the drug's label.

http://.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm.

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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© 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
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
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 workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
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