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  2. Approved Drug Products with Therapeutic Equivalence ...

    en.wikipedia.org/wiki/Approved_Drug_Products...

    Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the Orange Book contains therapeutic equivalence evaluations (2 character rating codes) for approved multisource prescription drug products ( generic drugs ).

  3. List of drugs granted breakthrough therapy designation

    en.wikipedia.org/wiki/List_of_drugs_granted...

    Amgen. non-small cell lung cancer with KRAS G12C mutation. Avapritinib. Blueprint Medicines Corp. granted for two indications: mast cell leukemia and advanced systemic mastocytosis. Belumosudil. Kadmon Pharmaceuticals. chronic graft-versus-host disease. Pembrolizumab.

  4. Structured Product Labeling - Wikipedia

    en.wikipedia.org/wiki/Structured_Product_Labeling

    Structured Product Labeling. Structured Product Labeling ( SPL) is a Health Level Seven International (HL7) standard which defines the content of human prescription drug labeling in an XML format. [1] The "drug labeling" includes all published material accompanying a drug, such as the Prescribing Information which contains a great deal of ...

  5. List of therapeutic monoclonal antibodies - Wikipedia

    en.wikipedia.org/wiki/List_of_therapeutic...

    This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.

  6. National drug code - Wikipedia

    en.wikipedia.org/wiki/National_Drug_Code

    The national drug code is a unique 10 or 11 digit, 3-segment numeric identifier assigned to each medication listed under Section 510 of the US Federal Food, Drug, and Cosmetic Act. The segments identify the labeler or vendor, product (within the scope of the labeler), and trade package (of this product). The first segment, the labeler code, is ...

  7. Generally recognized as safe - Wikipedia

    en.wikipedia.org/wiki/Generally_recognized_as_safe

    Generally recognized as safe ( GRAS) is a United States Food and Drug Administration (FDA) designation that a chemical or substance added to food is considered safe by experts under the conditions of its intended use. [1] An ingredient with a GRAS designation is exempted from the usual Federal Food, Drug, and Cosmetic Act (FFDCA) food additive ...

  8. List of progestogens available in the United States - Wikipedia

    en.wikipedia.org/wiki/List_of_progestogens...

    This is a list of progestogens (progesterone and progestins) and formulations that are approved by the FDA Tooltip Food and Drug Administration in the United States. Progestogens are used as hormonal contraceptives, in hormone replacement therapy for menopausal symptoms, and in the treatment of gynecological disorders.

  9. List of pharmaceutical compound number prefixes - Wikipedia

    en.wikipedia.org/wiki/List_of_pharmaceutical...

    This list of pharmaceutical compound number prefixes provides codes used by individual pharmaceutical companies when naming their pharmaceutical drug candidates. . Pharmaceutical companies generally produce large numbers of compounds in the research phase for which it is impractical to use often long and cumbersome systematic chemical names, and for which the effort to generate nonproprietary ...