orange book


Also found in: Dictionary, Thesaurus, Legal, Financial, Encyclopedia, Wikipedia.

Orange Book

Graduate education-UK
A guide to specialist registrar training issued by NHSE, for doctors who entered training programmes before 2007.

Medspeak-US
A document produced by the US Government Printing Office, which identifies FDA-approved brand medications and generic bioequivalents.

orange book

The "Approved Drug Products with Therapeutic Equivalence Evaluations" published by the U.S. Food and Drug Administration in both bound and electronic formats.
References in periodicals archive ?
(11) Along with the NDA, the pioneer must also submit patent information for "any patent which claims the drug for which the applicant submitted the application or which claims a method of using such drug." (12) The FDA then publishes the patent information, along with patent expiration dates, in the Orange Book, to give notice to future generic drug applicants that the patent may block introduction of generic products.
The FDA unwittingly abets that abuse by allowing the firms to list new patents in the Orange Book for previously introduced drugs, and by extending automatic protection to the original drug even if the listed patents are invalid or irrelevant.
The established new CD-RW standard Orange Book Part II, Volume 1, Ver.
The US Patent and Trademark Office has issued patent number 10,010,533, which will expire in January 2031 and will be listed in the US Food and Drug Administration's (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).
The newly issued patent will be listed in the US FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) bringing its total Orange Book listed patents for BENDEKA to 13.
Summary: New Delhi [India], Dec 6 (ANI): India's largest online marketplace for automobiles Droom has announced expansion of the scope of Orange Book Value, popularly known as OBV, to give the fair market value of used mobile phones to the customers.
patents listed in the FDA's Orange Book for Abstral[R].
By acquiring Johnson Matthey's patent to the oxymorphone ingredient, which will be listed in the Food and Drug Administration's Orange Book, Endo will hold additional patent protection for its Opana franchise through 2029.
The patent, issued by the United States Patent and Trademark Office (USPTO), will be included in the Approved Drug Products list (so called Orange Book) of the US Food and Drug Administration (FDA).
Mike German said grassroots Lib Dems were "in no mood" for the kind of agenda detailed in last year's Orange Book.
Preservative & Additive Free, Rated AN in the Orange Book. Sterile PREDILUTED with normal saline.
The exclusivity afforded the patent listed in the Orange Book for Imitrex injection expires on February 6, 2009.