orange book

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Orange Book

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

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 ?
Prior to this newly listed patent, the Fanapt Orange Book listed patents were the U.
But Sir Menzies' supporters yesterday sought to downplay suggestions that the Winchester MP was the "modernisers" candidate, pointing out that several of the Orange Book MPs have already declared their support for their candidate.
The party must, however, decide on whether it has the stomach for the kind of economic liberalism set out by young Turks like David Laws in the Orange Book.
My Orange Book was developed with the help of pupils from Ysgol Hen Felin, in Ystrad.
Under the Hatch-Waxman Act, for each patent listed in the Orange Book for the relevant branded drug, an ANDA applicant must certify one of the following claims: (1) that such patent information has not been filed; (2) that such patent has expired; (3) that the proposed drug will not be marketed until expiration of the patent; or (4) that either the proposed generic drug does not infringe the patent or the patent is invalid, otherwise known as Paragraph IV certification.
Under the act, firms are to list their patents in the FDA's Orange Book.
For example, if I open the Orange Book to "There is a river, the stream whereof etc.
Ricoh has developed this disc compatible with writing/rewriting speeds of 4x to 10x to conform with the CD-RW standard, Orange Book Part III, Volume 2, Ver.
Information in The Orange Book is also valid for orange nectars and other varieties of fruit juice.
The Food and Drug Administration (FDA) rates generic drugs in its official publication, Approved Drug Products with Therapeutic Equivalence Evaluations, known to pharmacists as "the orange book.
Patents are considered listed in the Orange Book upon receipt by FDA, and this is one of three patents for daptomycin listed in the Orange Book.
The Settlement Agreement offers that Ranbaxy's current product, which is the subject of its ANDA does not infringe Acura's Orange Book listed patents with the FDA.