Development And Review Process Of NDA, ANDA/AADA and OTC

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This document summarizes different types of new drug applications and reviews processes in the United States, including NDAs, ANDAs, and OTC monographs. It discusses the requirements for NDAs including chemistry, manufacturing, clinical trials, and safety data. ANDAs allow for generic drug approval by referencing an already approved drug. OTC monographs provide standards for active ingredients, doses, and labeling of non-prescription drugs. The review processes for these application types and OTC monographs are also briefly outlined.

Educação Saúde e medicina Negócios

Development and Review Process of NDA, ANDA/AADA and OTC Dr. Basavaraj K. Nanjwade M. Pharm., Ph. D Associate Professor Department of Pharmaceutics KLE University BELGAUM – 590 010

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New Drug Application (NDA) Classifications ,[object Object],[object Object],[object Object],[object Object]

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ANDA/AADA (Abbreviated New Drug Application) ,[object Object]

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ANDA/AADA (Abbreviated New Drug Application) ,[object Object],[object Object]

OTC (Over-the-Counter Drug Products) ,[object Object],[object Object],[object Object]

THANK YOU E-mail: [email_address] Cell No: 09448716277

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