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E-Book/E-Doc

Title Guidance for industry [electronic resource] : changes to an approved NDA or ANDA, questions and answers.

Imprint Rockville, MD : U.S. Dept. of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, [2001]

Copies

Location Call No. OPAC Message Status
 Axe Federal Documents Online  HE 20.4702:N 42/2    ---  Available
Description 1 electronic resource (11 p.)
Note "CMC."
"January 2001."
Subject Drug approval -- United States.
Added Author Center for Drug Evaluation and Research (U.S.)
Added Title Changes to an approved NDA or ANDA, questions and answers.
Gpo Item No. 0499-T (online)
Sudoc No. HE 20.4702:N 42/2

 
    
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