Difference between revisions of "Application Number"

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'''FDA Application Number'''
 
'''FDA Application Number'''
 
This number, also known as the [[NDA]] ([[New Drug Application]]) number, is assigned by [[FDA]] staff to each application for approval to market a new drug in the United States. One drug can have more than one application number if it has different dosage forms or routes of administration
 
This number, also known as the [[NDA]] ([[New Drug Application]]) number, is assigned by [[FDA]] staff to each application for approval to market a new drug in the United States. One drug can have more than one application number if it has different dosage forms or routes of administration
 
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==Requesting an Application Number==
  
 
[[Category:RPS Glossary]]
 
[[Category:RPS Glossary]]

Latest revision as of 14:41, 29 September 2008

A unique number assigned by Health Authorities to applications which have been submitted by sponsors for review.

Additional Regional Definitions and Synonyms

FDA Application Number This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in the United States. One drug can have more than one application number if it has different dosage forms or routes of administration

Requesting an Application Number