We use cookies to improve security, personalize the user experience, enhance our marketing activities (including cooperating with our marketing partners) and for other business use.
Click "here" to read our Cookie Policy. By clicking "Accept" you agree to the use of cookies. Read less
Read more
Accept
Loading
Form preview
  • US Legal Forms
  • Form Library
  • More Forms
  • More Multi-State Forms
  • Administration (fda) Is Withdrawing

Get Administration (fda) Is Withdrawing

Laboratories Ltd., c/o Ranbaxy Inc. (Ranbaxy), 600 College Rd. East, Princeton, NJ 08540. The drug products are no longer marketed, and Ranbaxy has requested that the approval of the applications be withdrawn. DATES: Effective date: September 21, 2012. SUMMARY: FOR FURTHER INFORMATION CONTACT: Florine P. Purdie, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6366, Silver Spring, MD 20993 0002, 301 796 3601. SUPPLEMENTARY I.

How it works

  1. Open form

    Open form follow the instructions

  2. Easily sign form

    Easily sign the form with your finger

  3. Share form

    Send filled & signed form or save

How to fill out the Administration (FDA) Is Withdrawing online

Filling out the Administration (FDA) Is Withdrawing form online can seem daunting, but this guide provides clear and supportive instructions to help you complete each section effectively. With a focus on user-friendly guidance, this document aims to simplify your experience in managing this crucial process.

Follow the steps to successfully fill out the Administration (FDA) Is Withdrawing form online.

  1. Click ‘Get Form’ button to access the Administration (FDA) Is Withdrawing form and open it in your preferred editing tool.
  2. Begin by entering your personal information in the designated fields. Ensure that all information is accurate to avoid delays. Provide your name, contact information, and any relevant identification numbers as required.
  3. Next, navigate to the section that requests information about the drug products associated with the withdrawal. Carefully input the application numbers from the provided list, ensuring that each entry matches the corresponding drug product accurately.
  4. Review the section outlining the reasons for the withdrawal. Provide a clear explanation based on the relevance of the request submitted by the manufacturer, ensuring adherence to any stipulations mentioned in related legal documents.
  5. Complete any additional sections regarding consent or approvals required for submission. Make sure all requisite signatures and acknowledgments are included to demonstrate compliance with FDA requirements.
  6. Once all fields are filled out correctly, review the entire document for errors or omissions. It is advisable to have a second pair of eyes review the form to catch any potential mistakes.
  7. Finally, you can save your changes, download the completed form for your records, print it out if necessary, or share it as required through the appropriate channels.

Ready to proceed? Complete your Administration (FDA) Is Withdrawing form online today!

Get form

Experience a faster way to fill out and sign forms on the web. Access the most extensive library of templates available.
Get form

Related content

21 CFR 314.152 -- Notice of withdrawal of approval...
If the Food and Drug Administration withdraws approval of an application or abbreviated...
Learn more
It Takes the FDA 46 Months to Withdraw a Failed...
Mar 29, 2023 — From 2009 to 2022, the AA program approved 48 drugs and 66...
Learn more
Orange Book Questions and Answers Guidance for...
Form FDA 3542 within 15 days of FDA's original notification.33 NDA holders should. 279...
Learn more

Related links form

CWH Next Generation Entry-Level Firefighter/EMT... - Nashville Roof Hazards Assesement Atlanta Public Schools - Applicant Tracking System - 050715-01 Mckesson Breast Pump

Questions & Answers

Get answers to your most pressing questions about US Legal Forms API.

Contact support

At present, both Congress and the executive branch exercise broad influence over the FDA, while the courts serve as a check on agency authority.

The U.S. Food and Drug Administration is a federal regulatory agency in the Department of Health and Human Services.

FDA Mission The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

IND Withdrawal In ance with 21CFR312. 38, a sponsor may withdraw an effective IND without prejudice at any time. The withdrawal can be initiated if a study is complete and the follow-up period has ended, or if development of the investigational product has been abandoned for any reason.

The FDA is a part of the Department of Health and Human Services.

(c) FDA will withdraw approval of an application or abbreviated application if the applicant requests its withdrawal because the drug subject to the application or abbreviated application is no longer being marketed, provided none of the conditions listed in paragraphs (a) and (b) of this section applies to the drug.

A market withdrawal is a firm's removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by the FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc.

The Department of Health and Human Services, which includes the Food and Drug Administration, is in the Executive branch. The Executive branch implements and enforces the laws that Congress enacts, sometimes issuing regulations to do so.

Get This Form Now!

Use professional pre-built templates to fill in and sign documents online faster. Get access to thousands of forms.
Get form
If you believe that this page should be taken down, please follow our DMCA take down processhere.

Industry-leading security and compliance

US Legal Forms protects your data by complying with industry-specific security standards.
  • In businnes since 1997
    25+ years providing professional legal documents.
  • Accredited business
    Guarantees that a business meets BBB accreditation standards in the US and Canada.
  • Secured by Braintree
    Validated Level 1 PCI DSS compliant payment gateway that accepts most major credit and debit card brands from across the globe.
Get Administration (FDA) Is Withdrawing
Get form
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
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