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June 3, 2022
Published by Med Search on June 3, 2022
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For specific application or supplement questions, please contact For general questions about the Prescribing Information or this website contact the Labeling Policy Team in CDER. *For the purposes of […]
June 3, 2022
Published by Med Search on June 3, 2022
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Boxed Warning (sometimes referred to in lay terms as a “black-box warning”) Contains contraindications or warnings about serious adverse reactions2 that may lead to death or […]
June 3, 2022
Published by Med Search on June 3, 2022
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Biological products, including biosimilar and interchangeable biosimilars, are large and generally complex molecules. A biological product may weigh more than 800 times than a drug product (e.g., […]
June 3, 2022
Published by Med Search on June 3, 2022
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Who Is the Audience for This Website? FDA’s generic drug-specific labeling resources are primarily directed to industry staff who develop generic drug labeling. For more information […]
June 3, 2022
Published by Med Search on June 3, 2022
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This supplementary webpage is primarily directed to Structured Product Labeling (SPL) developers to assist in selection of appropriate SPL codes for human prescription drug* labeling. See […]
June 3, 2022
Published by Med Search on June 3, 2022
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On this webpage Who Is the Audience for This Website? FDA’s carton and container labeling specific resources on this webpage are primarily directed to industry staff […]
June 3, 2022
Published by Med Search on June 3, 2022
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On this page Who is the audience for this webpage? FDA’s patient labeling specific resources on this webpage are primarily directed to industry staff who develop […]
June 3, 2022
Published by Med Search on June 3, 2022
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Who is the Audience for This Webpage? FDA’s Prescribing Information (PI) resources on this webpage are primarily directed to industry staff who develop PI. For other […]
June 3, 2022
Published by Med Search on June 3, 2022
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FDA’s labeling resources for human prescription drugs are primarily directed to industry staff who develop human prescription drug* labeling. Human prescription drug labeling (1) contains a […]
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