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NDA 18-651/S-021 Page 3 500012 Rev Sep 2004 () Capsules DESCRIPTION is a cannabinoid designated chemically as (6aR-trans)-6a,7,8,10a-tetrahydro-6,6,9trimethyl-3-pentyl-6H-dibenzo b, d pyran-1-ol.
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What is nda 18-651s-021 - fda?
NDA 18-651S-021 - FDA is a specific New Drug Application (NDA) submitted to the U.S. Food and Drug Administration (FDA) for review and approval.
Who is required to file nda 18-651s-021 - fda?
The pharmaceutical company or manufacturer developing the new drug is required to file NDA 18-651S-021 - FDA.
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NDA 18-651S-021 - FDA must be filled out completely and accurately with all relevant information about the new drug, its composition, intended use, and supporting data.
What is the purpose of nda 18-651s-021 - fda?
The purpose of NDA 18-651S-021 - FDA is to seek approval from the FDA to market and distribute the new drug in the United States.
What information must be reported on nda 18-651s-021 - fda?
Information such as preclinical and clinical data, manufacturing processes, labeling, and safety and efficacy profiles of the new drug must be reported on NDA 18-651S-021 - FDA.
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