Home > Term: pharmaceutical equivalents
pharmaceutical equivalents
FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:
- they contain the same active ingredient(s)
- they are of the same dosage form and route of administration
- they are identical in strength or concentration
- shape
- release mechanism
- labeling (to some extent)
- scoring
- excipients (including colors, flavors, preservatives)
- Part of Speech: noun
- Industry/Domain: Pharmaceutical
- Category: Drugs
- Company: U.S. FDA
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(United States)