Abbreviated New Drug Application (ANDA) | PharmaBharat Tools

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Abbreviated New Drug Application (ANDA) | PharmaBharat Tools

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Abbreviated New Drug Application(ANDA)IND Annual Report Active Substance Master File(ASMF)Biologics License Application(BLA)Center for Drug Evaluation and Research(CDER)Certificate of Suitability(CEP)Clinical Hold Clinical Trial Application(CTA)Drug Master File(DMF)DMF Type II DMF Type III DMF Type IV DMF Type V FDA Form 1571 FDA Form 356h FDA Form 3674 505(b)(2) Application(505(b)(2))Investigational New Drug(IND)Initial Pediatric Study Plan(iPSP)Letter of Authorization(LoA)Marketing Authorisation Application(MAA)New Drug Application(NDA)Orange Book Reference Listed Drug(RLD)Supplement

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RA Regulatory SubmissionsAbbreviated New Drug Application

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IND Annual Report

Abbreviated New Drug Application(ANDA)

Regulatory Submissions

Definition

A US application for approval of a generic drug, typically based on bioequivalence to a reference listed drug (RLD) and quality/CMC data, without repeating full clinical efficacy trials.

Example

A generic manufacturer files an ANDA with BE study reports and CMC information for an immediate-release tablet.

Regulatory source

FD&C Act 505(j), 21 CFR 314