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Frequently Asked Questions

What is the FDA’s Orange Book?

One of FDA’s most-used resources, the Orange Book lists approved prescription drugs, related patent and exclusivity information, and therapeutic equivalence evaluations, along with other information. The evaluations it contains serve as public information and advice to state health agencies, prescribers, health care providers, and pharmacists.

What is the Orange Book of therapeutic equivalence?

The Orange Book is the only official source for therapeutic equivalence evaluations and reference listed drug (RLD) data for FDA-approved generic and brand-name drugs. FDA evaluates approved multiple-source drugs for therapeutic equivalence and assigns a rating code which appears in the Orange Book.

What is the strength of drug products in the Orange Book?

Although the strength of drug products in the Orange Book is generally expressed in terms of the amount of drug substance (active ingredient) in the drug product, it is sometimes expressed in terms of the amount of the active moiety.

Are drug products of distributors and/or repackagers included in the Orange Book?

Even though drug products of distributors and/or repackagers are not included in the Orange Book, they are considered therapeutically equivalent to the applicant’s drug product if the applicant’s drug product is rated either with an AB or three-character code or is single source in the Orange Book.


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