Back to the Top
Dear all, would please refer me to a web site or an article that
differentites between the NDA and ANDA for all dosage forms.
Thank you
Back to the Top
Hi,
I suggest you refer to
http://www.fda.gov/cder/regulatory/applications/default.htm for
introduction to IND, NDA and ANDA.
Sunil Vandse
Back to the Top
Dr. Mutasiim Al-Ghazawi:
US FDA's website or U.S. Codes of Federal Regulation (CFR) contains
some information about NDA/ANDA. Following the links below, type the
keyword 'ANDA':
http://www.fda.gov/cder/guidance/
http://www.access.gpo.gov/cgi-bin/cfrassemble.cgi?title=199921
Good luck,
CQ Deng
Back to the Top
Dr. Mutasim Al-Ghazawi
It is very simple to differentiate between NDA and ANDA. NDA stands
for some newer chemical moiety or some new invention or new dosage form
where as ANDA is just generic version of thge exisiting products.
Tushar Nahata
PharmPK Discussion List Archive Index page
Copyright 1995-2010 David W. A. Bourne (david@boomer.org)