Search results
Results from the WOW.Com Content Network
The certificate of pharmaceutical product (abbreviated: CPP) is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product and of the applicant for this certificate in the exporting country; [1] it is often mentioned in conjunction with the electronic Common Technical Document (eCTD).
The CLP Regulation [1] (for "Classification, Labelling and Packaging" [2]) is a European Union regulation from 2008, which aligns the European Union system of classification, labelling and packaging of chemical substances and mixtures to the Globally Harmonised System (GHS). It is expected to facilitate global trade and the harmonised ...
This list is organized by type of agent, although the subsections are not necessarily definitive and are subject to revision. Each drug is listed once (at present), though it might fall in more than one subsection. A full alphabetical listing is included after the categorical listing.
Many drugs have more than one name and, therefore, the same drug may be listed more than once. Brand names and generic names are differentiated by capitalizing brand names. See also the list of the top 100 bestselling branded drugs, ranked by sales. Abbreviations are used in the list as follows: INN = International nonproprietary name
List of drugs: A; List of drugs: A–Ab; List of drugs: Ac; List of drugs: Ad–Ak; List of drugs: Al; List of drugs: Am; List of aminorex analogues; List of drugs: An–Ap; List of antileukemic drugs; List of drugs: Aq–Ar; List of arylcyclohexylamines; List of drugs: As–Az
Many drugs have more than one name and, therefore, the same drug may be listed more than once. Brand names and generic names are differentiated by capitalizing brand names. See also the list of the top 100 bestselling branded drugs, ranked by sales. Abbreviations are used in the list as follows: INN = International Nonproprietary Name
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.
Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them. In order for a generic drug manufacturer to win approval of a drug under the Hatch-Waxman Act, the generic manufacturer must certify that they will not launch their generic until after the expiration of the Orange Book-listed patent ...