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Supplement
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.
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- Part of Speech: noun
- Synonym(s):
- Blossary:
- Industry/Domain: Pharmaceutical
- Category: Drugs
- Company: U.S. FDA
- Product:
- Acronym-Abbreviation:
Other Languages:
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