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)