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  1. 1 kwi 2024 · FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information about: Other prescription drug...

  2. www.dailymed.nlm.nih.gov › dailymedDailyMed

    15 wrz 2021 · DailyMed contains labeling for prescription and nonprescription drugs for human and animal use, and for additional products such as medical gases, devices, cosmetics, dietary supplements, and medical foods.

  3. 16 mar 2021 · The drug information label for the generic medicine should be the same as the brand-name label. One exception is if the brand-name drug is approved for more than one use and that use is...

  4. The European Medicines Agency (EMA) assesses applications from companies to market generic medicines in the European Union (EU). A generic medicine is developed to be the same as a medicine that has already been authorised, called the reference medicine.

  5. Drugs @ FDA, where information about FDA-approved human brand name and generic drugs as well as therapeutic biological products is available. Biologics Products and Establishments , where...

  6. 1 kwi 2024 · Labeling for prescription medicines is required for all FDA-approved prescription medicines. Such labeling is: Proposed by the drug company, Reviewed by the FDA, and. If acceptable,...

  7. 3 gru 2020 · The drug labeling information for biosimilars compares the reference product more comprehensively than traditional generic drugs. This ensures that prescribers have clear access to the source of information, enabling them to understand the therapeutic profile associated with each biosimilar agent.

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