Abstract

ABBREVIATED NEW DRUG APPLICATION (ANDA) FILING CHECKLIST

S. K. Sharmila*, Brahmaiah Bonthagarala, M. V. Nagabhushanam, G. Ramakrishna, Sharmila Y. Ratna Sindhu

ABSTRACT

This paper is intended to assist applicants in preparing abbreviated new drug applications (ANDAs) for submission to FDA under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance details the information that should 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 applicants in preparing their ANDA submission. This guidance identifies the information that an applicant should include to ensure that a complete, high-quality application is submitted to FDA. FDA has previously published guidance documents on the filing process, including the guidance for industry about refuse-to-receive standards, and common, recurring deficiencies which should be reviewed thoroughly prior to submission of an ANDA. ANDA Content Differences with 505(b)2 Emerging Initiatives Summary ANDA Submission Checklist FDA ANDA Review Checklist ANDA Process for Generic Drugs ANDA Checklist for CTD or ECTD Format for Completeness and Acceptability of an Application for Filing Guidance for Industry Organization of an ANDA.

Keywords: Abbreviated New Drug Application (ANDA), Common Technical Document (CTD), Check List, USFDA.