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Why is the Established Name Important? •The drug product name (esp. the dosage form) affects: –Exclusivity determinations –Generic products (different technology, same dosage form)
In the B3/C3 formats, the Preferred Names are generic for both single and multi-ingredient records, i.e. they represent the substance or substance combination. Please note that the single
In the United States under the Federal Food, Drug, and Cosmetic Act (FDCA), the official name given to a drug plays a critical role. The FDCA defines the term “official compendium,” in part, as the official USP, the official NF, or any supplement to either of them.
compilation of the U.S. Adopted Names (USAN) published from the start of the USAN program in 1961, as well as other names for drugs, both current and retrospective, is provided in the USP Dictionary of USAN and International Drug Names.
WHODrug is distributed in two formats, the B3 format and the C3 format. The C3 format contains Drug codes, drug names, ingredients (excluding excipients), ATC classifications, countries in which the drugs are marketed, Marketing Authorisation Holders (MAH), pharmaceutical forms, and strengths.
Generic names tend to follow patterns, with prefixes, Roots, and suffixes often determining the class of medication. The following table gives a list of the prefix, root, and suffix for some common medications. Printable PDF version. Printable PDF version (Not shaded to save ink)
1 Φεβ 2018 · Administration (FDA) regulations at 21 CFR 299.5. The FDCA requires all drugs to have an “established name,” which is a nonproprietary name, other than the applicable systematic chemical name. The established name is almost always tied to the drug name recognized in USP-NF. USP and
