U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

Levothyroxine Sodium Products Enforcement of August 14, 2001 Compliance Date and Submission of New Applications July 2001

Download the Final Guidance Document Read the Federal Register Notice
Final
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance discusses how FDA plans to exercise its enforcement discretion after August 14, 2001, with regard to levothyroxine sodium products that are marketed without approved applications. This guidance also answers certain frequently asked questions concerning the submission of applications for levothyroxine sodium products. It replaces the previously issued guidance Levothyroxine Sodium, Questions and Answers (February 2001).

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

Back to Top