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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:761100Orig1s000
PRODUCT QUALITY REVIEW(S)Department of Health and Human Services
Food and Drug Administration
Center for Drug Evaluation
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What is non-proprietary name -dttb?
Non-proprietary name -dttb is the official generic name of a drug or medication.
Who is required to file non-proprietary name -dttb?
Manufacturers, distributors, and marketers of drugs or medications are required to file non-proprietary name -dttb.
How to fill out non-proprietary name -dttb?
Non-proprietary name -dttb can be filled out online through the designated regulatory agency's website or by submitting a physical form.
What is the purpose of non-proprietary name -dttb?
The purpose of non-proprietary name -dttb is to ensure transparency and standardization in the naming of drugs and medications.
What information must be reported on non-proprietary name -dttb?
Non-proprietary name -dttb typically requires information such as the active ingredient, strength, dosage form, and manufacturer of the drug or medication.
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