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CENTER FOR DRUG EVALUATION AND
RESEARCH
APPLICATION NUMBER:761028Orig1s000
OTHER REVIEW(S)MEMORANDUM
PROPRIETARY NAME SUFFIX
Division of Medication Error Prevention and Analysis (MEPA)
Office of Medication
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How to fill out nonproprietary name suffix

How to fill out nonproprietary name suffix
01
Start by locating the nonproprietary name field on the required form.
02
If the nonproprietary name has a suffix, such as Jr. or III, enter it in the designated suffix field.
03
If the form does not have a specific suffix field, add the suffix directly after the nonproprietary name, separated by a comma and a space.
04
Double-check the filled-out form to ensure accuracy and completeness.
05
Submit the form as instructed by the relevant authority.
Who needs nonproprietary name suffix?
01
Nonproprietary name suffixes are typically required for individuals who have a suffix as part of their legal name.
02
Examples of individuals who may need to include a nonproprietary name suffix are those with generational suffixes (Jr., Sr., III), professional suffixes (MD, PhD), or honorary suffixes (Esq., CBE).
03
The specific requirements for including nonproprietary name suffixes may vary depending on the purpose of the form or document.
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What is nonproprietary name suffix?
Nonproprietary name suffix is the addition at the end of the nonproprietary name of a drug to differentiate it from other drugs with the same nonproprietary name.
Who is required to file nonproprietary name suffix?
Manufacturers, sponsors, or applicants of new drug applications (NDAs) are required to file nonproprietary name suffix.
How to fill out nonproprietary name suffix?
Nonproprietary name suffix can be filled out on the appropriate forms provided by the regulatory authority overseeing drug approvals.
What is the purpose of nonproprietary name suffix?
The purpose of nonproprietary name suffix is to prevent confusion and ensure safety by differentiating drugs with similar names.
What information must be reported on nonproprietary name suffix?
Nonproprietary name suffix must include a unique identifier to distinguish the drug from others with the same name.
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