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Qdossier Qsauri
"S"

supplement
Guideline or reference source
FDA www.fda.gov
Definition
A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.
Related Term
supplement number
supplement type
 

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