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Year : 2021, Volume : 14, Issue : 1
First page : ( 506) Last page : ( 512)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2021.00092.5

An overview on post approval changes to an approved ANDA in US-FDA

Ahmed Syed Shakeeb, Shailesh T*, Kumar Hemanth S, Gangadharappa H.V, Gowrav M P

Pharmaceutical Quality Assurance Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS Academy of Higher Education and Research, Mysuru, Sri Shivarathreeshwara Nagara, Mysuru-570015, Karnataka, India

*Corresponding Author E-mail: shailesht@jssuni.edu.in

Online published on 22 April, 2021.


Post approval changes are the non-avoidable changes due to the many reasons for improving products quality and safety. According to US-FDA the changes which are made after the approval of the product are supposed to be reported as major, moderate and minor changes based on the impact on the process and filings. The post approval changes to approved generic products according to US-FDA regulations are the changes which includes the contents and composition, production sites changes, manufacturing or production process changes, container and closure system changes, specification changes, labeling changes and other miscellaneous changes. Hence United States regulatory authority requires that all changes to be thoroughly reviewed by the regulatory team before any changes are implemented for the particular commercialized product. The current study endeavours on the role post approval changes to the approved generic product or ANDA application.



Post Approval change, Generic Drugs, US-FDA, ANDA.


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