finished dosage form
- Guideline or reference source
- FDAGDUFA Generic Drug User Fee Amendments 2012
- Definition
- A) a drug product in the form in which it will be administered to a patient, such as a tablet, capsule, solution, or topical application; (B) a drug product in a form in which reconstitution is necessary prior to administration to a patient, such as oral suspensions or lyophilized powders; or (C) any combination of an active pharmaceutical ingredient, as defined in paragraph (m)(2), with another component of a drug product for purposes of production of such a drug product.
- Related Term
- pharmaceutical dose form
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