Revising ANDA Labeling Following Revision of the RLD Labeling Guidance for Industry: Guidance for Industry

Description

This guidance is intended to assist applicants and holders of an abbreviated new drug application (ANDA) in updating their labeling following revisions to the approved labeling of a reference listed drug (RLD). This guidance provides recommendations on identifying RLD labeling updates and submitting ANDA amendments or supplements to update generic drug labeling. This guidance revises the guidance for industry Revising ANDA Labeling Following Revision of the RLD Labeling (April 2000). After it has been finalized, this guidance will replace the April 2000 guidance. Significant changes from the 2000 version include updates to outdated details about how to obtain information on changes to RLD labeling and how to submit revised ANDA labeling to FDA.

Scope & Applicability

Regulatory Context

• 21CFR314.3§ 314.3 Definitions.

  (a) The definitions and interpretations contained in section 201 of the Federal Food, Drug, and Cosmetic Act apply to those terms when used in this part and part 320 of this chapter .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 →

• 21CFR314.127§ 314.127 Refusal to approve an ANDA.

  (a) FDA will refuse to approve an ANDA for a new drug under section 505(j) of the Federal Food, Drug, and Cosmetic Act for any of the following reasons, unless the requirement has been waived under § 314.99 :Read full regulation →

• 21CFR314.93§ 314.93 Petition to request a change from a listed drug.

  (a) The only changes from a listed drug for which the agency will accept a petition under this section are those changes described in paragraph (b) of this section. Petitions to submit ANDAs for other changes from a listed drug will not be approved.Read full regulation →

• 21CFR201.56§ 201.56 Requirements on content and format of labeling for human prescription drug and biological products.

  (a) General requirements. Prescription drug labeling described in § 201.100(d) must meet the following general requirements:Read full regulation →

• 21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.

  (a) Changes to an approved NDA.Read full regulation →

• 21CFR314.71§ 314.71 Procedures for submission of a supplement to an approved application.

  (a) Only the applicant may submit a supplement to an application.Read full regulation →

• 21CFR314.150§ 314.150 Withdrawal of approval of an application or abbreviated application.

  (a) The Food and Drug Administration will notify the applicant, and, if appropriate, all other persons who manufacture or distribute identical, related, or similar drug products as defined in §§ 310.6 and 314.151(a) of this chapter and for a new drug afford an opportunity for a hearing on a proposalRead full regulation →

• 21CFR314.96§ 314.96 Amendments to an unapproved ANDA.

  (a) ANDA.Read full regulation →

• 21CFR314.97§ 314.97 Supplements and other changes to an approved ANDA.

  (a) General requirements. The applicant must comply with the requirements of §§ 314.70 and 314.71 regarding the submission of supplemental ANDAs and other changes to an approved ANDA.Read full regulation →

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