Guidance for Industry

By Global Compliance Seminar (LinkedInTwitter)

ANDA Submissions-Content and Format of Abbreviated New Drug Applications

June 2014

This guidance is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to the Food and Drug Administration (FDA) under section 505(j) of the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(j)). This guidance details the information to be provided in each section of the Common Technical Document (CTD) format for human pharmaceutical product applications and identifies supporting guidance documents and recommendations issued by FDA to assist in preparing the submission.

This guidance does not address the fee structure or payment of obligations under the Generic Drug User Fee Amendments (GDUFA) and does not address the submission and assessment of drug master files (DMFs), amendments to original ANDAs, and changes being effected or prior approval supplements.

This guidance identifies the information an applicant should include to ensure that a complete,  high-quality application is submitted to FDA. FDA has previously published guidance on the filing process, including the refuse-to-receive standards, which should be reviewed thoroughly to avoid common deficiencies found in ANDA submissions.

Procedures for ANDAs submissions are set forth in FDA’s regulations in part 314 (21 CFR part 314). An ANDA is usually  submitted for a drug product that is the same as an already approved drug or listed drug. A listed drug is defined in § 314.3(b) as a new drug product that has an effective approval under section 505(c) of the FD&C Act for safety and effectiveness or under section 505(j) of the FD&C Act, which has not been withdrawn or suspended under section 505(e)(1) through (e)(5) or (j)(5) of the FD&C Act, and which has not been withdrawn from sale for what FDA has determined are reasons of safety or effectiveness (§ 314.161). An applicant submits an ANDA based on a listed drug, and the previously approved drug product on which the ANDA relies is officially known as the reference listed drug (RLD). A reference listed drug (RLD) is defined as the listed drug identified by FDA as the drug product upon which an applicant relies in seeking approval of its abbreviated application (§ 314.3(b)). FDA lists approved drugs that may be referenced in an ANDA in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book). The Orange Book is updated by a monthly cumulative supplement.

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Last Updated: 2016-04-18

ANDA Submissions-Content and Format
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