Generic Drug Facts | FDA
2021年11月1日 · FDA staff monitor approved brand-name and generic drug products to make certain that medicines at all levels of the supply chain, from the active pharmaceutical …
Drug Name Review | FDA - U.S. Food and Drug Administration
Before any drug reaches the market, its name is thoroughly examined to identify misleading or potentially confusing names. FDA Drug Info Rounds pharmacists discuss FDA’s responsibility …
Novel Drug Approvals for 2024 | FDA
2024年12月20日 · Drug Name Active Ingredient Approval Date FDA-approved use on approval date* 48. Tryngolza: olezarsen: 12/19/2024: To treat familial chylomicronemia syndrome: 47. …
confusion with existing drug names.6 In July 2006, the IOM published a follow-up report titled Preventing Medication Errors, which emphasized in part that proprietary name design should
Approved Drug Products with Therapeutic Equivalence Evaluations ...
2025年1月10日 · The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the …
FDA List of Authorized Generic Drugs | FDA - U.S. Food and Drug ...
2024年10月8日 · A generic drug, as that term is commonly understood and referred to by health care providers and insurers, is a copy of a brand-name drug that is developed and made by a …
Drug Approvals and Databases | FDA - U.S. Food and Drug …
CDER highlights key Web sites. Web page provides quick links to everything from acronyms to wholesale distributor and third-party logistics providers reporting. Additional topics include: …
Find Information about a Drug | FDA
2022年8月9日 · Find Drug Information on MedlinePlus. Easy-to-use resource from NIH with information about side effects, dosage, special precautions, and more for prescription and …
Generic Drugs: Questions & Answers | FDA - U.S. Food and Drug ...
A generic drug is a medication created to be the same as an already marketed brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, …
18 [Drug] If the Active Ingredient is a: •“Non-salt” (e.g. ester, chelate, complex) –use the entire drug substance name •Salt –generally, use the name of active moiety –sometimes ...