Tag: FDA Orange Book

FDA Authorized Generics List: How to Access and Use It

Learn how to find and use the FDA's list of authorized generics. We explain where to access the official PDF, how to interpret market entry dates, and why these drugs differ from traditional generics in the Orange Book.

Therapeutic Equivalence Codes (TE Codes) Explained: What They Mean for Your Meds

Learn how Therapeutic Equivalence Codes (TE Codes) help determine if generic drugs are safe substitutes for brand-name medications. Understand the FDA's Orange Book, cost savings, and limitations.

Managing Different Doses in Combination Products: A Practical Guide to Therapeutic Equivalence

Therapeutic equivalence in combination products ensures safe substitution of generics, but dose differences and inactive ingredients can affect outcomes. Learn how to navigate FDA ratings, NTI risks, and real-world substitution pitfalls.