Description
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).
Scope & Applicability
Product Classes
1review and approval process for new drugs
Regulatory Context
Attributes
3they would be AB-rated to each other in the Orange Book
listed in the Orange Book as BX-rated drug products
FDA found that levothyroxine sodium products are medically necessary
Related CFR Sections (3)
- 21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
- 21CFR314.50§ 314.50 Content and format of an NDA.
NDAs and supplements to approved NDAs are required to be submitted in the form and contain the information, as appropriate for the particular submission, required under this section. Three copies of the NDA are required: An archival copy, a review copy, and a field copy. An NDA for a new chemical enRead full regulation →
- 21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
See Also (8)
- PET Drug Applications - Content and Format for NDAs and ANDAs_2011 (Status: Final)
- ANDA Submissions - Refuse-to-Receive Standards: Questions and Answers Guidance for Industry (Status: Draft)
- CVM GFI #132 Administrative Applications and the Phased Review Process (Status: Final)
- Applications Covered by Section 505(b)(2) (Status: Draft)
- Refuse to File: NDA and BLA Submissions to CDER Guidance for Industry (Status: Draft)
- Determining Whether to Submit an ANDA or a 505(b)(2) Application (Status: Final)
- ANDA Submissions – Prior Approval Supplements Under GDUFA: Guidance for Industry (Status: Final)
- CPG Sec. 400.210, Radiofrequency Identification Feasibility Studies and Pilot Programs for Drugs (Status: Final)