ANDA submissions--amendments to abbreviated new drug applications under GDUFA
Guidance for industry
United States. Department of Health and Human Services, issuing body. United States. Food and Drug Administration, issuing body. Center for Drug Evaluation and Research (U.S.), issuing body.
Silver Spring, MD : Center for Drug Evaluation and Research, July 2018
Drugs, Generic -- standards
Investigational New Drug Application
United States. Department of Health and Human Services.
United States. Food and Drug Administration.
The National Library of Medicine believes this item to be in the public domain.
1 online resource (1 PDF file (26 pages)).
NLM Unique ID:
See catalog record
Metadata (Dublin Core)