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CENTER FOR DRUG EVALUATION AND
RESEARCHAPPLICATION NUMBER:21560s000CLINICAL PHARMACOLOGY AND
BIOPHARMACEUTICS REVIEW(S)Office of Clinical Pharmacology:
Pharmacometric Review
NDA21560Drug Name:EverolimusSubmission
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Collect all the necessary information about the drug, such as the drug name, active ingredients, dosage form, and strength.
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What is drugsfda fda-approved drugs?
Drugsfda fda-approved drugs are medications that have received approval from the Food and Drug Administration (FDA) for use in the United States.
Who is required to file drugsfda fda-approved drugs?
Manufacturers or sponsors of drugs are required to file drugsfda fda-approved drugs with the FDA.
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To fill out drugsfda fda-approved drugs, manufacturers or sponsors must provide detailed information about the drug, its intended use, and any potential side effects.
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The purpose of drugsfda fda-approved drugs is to ensure that medications on the market are safe and effective for use by the public.
What information must be reported on drugsfda fda-approved drugs?
Information that must be reported on drugsfda fda-approved drugs includes the drug's name, active ingredients, dosage form, and indications for use.
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