Description
This guidance is intended to assist prospective applicants, applicants, and holders of abbreviated new drug applications (ANDAs) with optional attachments that can be used when preparing cover letters that accompany controlled correspondence2 to the Office of Generic Drugs (OGD), as well as original ANDAs, amendments to ANDAs, and supplements to approved ANDAs submitted to FDA. These attachments do not replace the recommendations for the content of cover letters provided in other FDA guidances.
Scope & Applicability
Product Classes
8topic of the guidance document
Product type covered by SUPAC-SS guidance.
Product type covered by SUPAC-IR guidance.
Product type covered by SUPAC-MR guidance.
Proprietary name and application number for RS
The drug product identified by the applicant for comparison; Comparison of ANDA product to RLD for pH adjuster differences
Products combining drug, device, or biological constituents; Generally recommended for Enhanced Documentation; Requires 14971-based framework incorporating ICH Q9; A drug-device combination where the device constituent part detects ingestion.
Products subject to manufacturing violations under section 501.
Stakeholders
4Entity submitting development data and knowledge; Entity performing the work process for change
Assists FDA in communications with foreign establishments
Entity preparing to submit an ANDA or controlled correspondence.
The entity that owns an approved Abbreviated New Drug Application.
Regulatory Context
Attributes
4Location of the cover letter in the eCTD hierarchy
Scale-Up and Post Approval Changes levels 1, 2, or 3.
Required information for RLD/RS and proposed products.; Product characteristic in ANDA background
controls in place to maintain the strength, composition, and purity
Related CFR Sections (5)
- 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
- 21CFR320.22§ 320.22 Criteria for waiver of evidence of in vivo bioavailability or bioequivalence.
(a) Any person submitting a full or abbreviated new drug application, or a supplemental application proposing any of the changes set forth in § 320.21(c) , may request FDA to waive the requirement for the submission of evidence measuring the in vivo bioavailability or demonstrating the in vivo bioeqRead full regulation →
- 21CFR58.3§ 58.3 Definitions.
As used in this part, the following terms shall have the meanings specified:Read full regulation →
- 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 →
- 21CFR314.96§ 314.96 Amendments to an unapproved ANDA.
(a) ANDA.Read full regulation →
See Also (8)
- Postapproval Changes to Drug Substances Guidance for Industry (Status: Draft)
- SUPAC-IR Questions and Answers about SUPAC-IR Guidance (Status: Final)
- Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry (Status: Draft)
- Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry (Status: Final)
- Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Q5D Quality of Biotechnological/Biological Products: Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products; Availability (Status: Final)
- For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Blood and Blood Components Intended for Transfusion or for Further Manufacture and For the Completion of the Form FDA 356h: Guidance for Industry (Status: Final)