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
Pharmaceutically equivalent drug products may differ in characteristics such as
- shape
- release mechanism
- labeling (to some extent)
- scoring
- excipients (including colors, flavors, preservatives)