Determining whether to submit an ANDA or a 505(b)(2) application

Determining whether to submit an ANDA or a 505(b)(2) application

Collection:
Health Policy and Services Research
Series Title(s):
Guidance for industry
Contributor(s):
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.
Publication:
Silver Spring, MD : Center for Drug Evaluation and Research, May 2019
Language(s):
English
Format:
Text
Subject(s):
Drug Approval
Drugs, Investigational
Investigational New Drug Application
United States
United States. Department of Health and Human Services
United States. Food and Drug Administration
United States.
Genre(s):
Technical Report
Copyright:
The National Library of Medicine believes this item to be in the public domain. (More information)
Extent:
1 online resource (1 PDF file (14 pages)).
NLM Unique ID:
101760090 (See catalog record)
Permanent Link:
http://resource.nlm.nih.gov/101760090