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ANDA approvals in 2019: Trends for the generics industry
US-FDA continued with its momentum of previous years and granted 833 final ANDA approvals in the year 2019, slightly higher than the 813 final approvals in 2018. Additionally, 146 Tentative Approvals were also granted during the calendar year 2019.
Using the Inactive Ingredient Database Guidance for Industry
This guidance describes the Food and Drug Administration’s (FDA’s) Inactive Ingredient Database (IID) and provides recommendations for how to use the IID in the development of drug products.
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