Orange book fda?

The FDA’s Orange Book is short for “Approved Drug Products with Therapeutic Equivalence Evaluations.” It’s a government resource that lists every FDA‑approved drug product and indicates whether a generic version is therapeutically equivalent to the brand/reference product.

What you can use it for
- Check if a generic is considered substitutable for a given brand or reference drug.
- See the therapeutic equivalence (TE) status for a specific dosage form.
- Find patent and exclusivity information that might affect when generics can come to market (for brand-name drugs).

What the TE codes mean (in brief)
- The entry shows a two-letter TE code for each dosage form. The first letter is A or B:
- A = therapeutically equivalent to the reference listed drug (generally substitutable).
- B = not therapeutically equivalent (not substitutable).
- The second letter/refinement further describes the specific dosage form and formulation. The FDA page includes a legend that explains these codes.

How to use it
- Search by active ingredient, brand name, or manufacturer on the FDA Orange Book site.
- Look at the TE code for the exact dosage form you’re using.
- If you see a status beginning with A, generic substitution is typically allowed for that product/formulation; a B status means caution or non‑substitution.

If you tell me a drug name and dosage form (e.g., “atorvastatin 20 mg tablet”), I can summarize the Orange Book TE status for that exact product, or guide you to the right entry.