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日期:2024-04-15
Orange Book: Approved Drug Products
with Therapeutic Equivalence ......
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日期:2024-04-19
U.S. Food & Drug Administration A to Z Index Follow FDA En Español Enter Search terms Most Popular Searches Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco ......
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日期:2024-04-18
Current through December 2014 To provide timely consumer information on generic drugs, the Electronic Orange Book is updated daily as new generic approvals occur. Publications FAQ Search by Active Ingredient Search by Applicant Holder Search by ......
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日期:2024-04-17
With the finalization of the Waxman-Hatch amendments that characterized each strength of a drug product as a listed drug it became evident that the format of the Orange Book should be changed to reflect each strength of a parenteral solution. To this end ...
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日期:2024-04-22
The Orange Book has long been a reliable resource for information about FDA-approved drugs. The electronic availability of the Orange Book brings this valuable tool to the web for healthcare professionals. FDA Drug Info Rounds pharmacists discuss how to s...
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日期:2024-04-17
The Food and Drug Administration's Orange Book is a list of drugs approved under section 505 of the Federal Food, Drug and Cosmetic Act for interstate commerce within the United States. The Orange Book is updated daily with new generic drug approvals. Kee...
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日期:2024-04-22
1 FDA Throws the (Purple) Book at Biosimilars—Purple v. Orange By Evert Uy Tu and Jeffrey A. Wolfson1 On September 9, 2014, the U.S. Food and Drug Administration (FDA) published the inaugural “Purple Book,” a list of approved or “licensed” biological ......
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日期:2024-04-21
Last week, the U.S. District Court for the District of Columbia denied Mylan's emergency motion for a temporary restraining order that would have forced FDA to relist Pfizer's Norvasc patent in the Orange Book. Until June 22, when FDA delisted Pfizer's pa...