Approved and Marketed Fast Dissolving/ Disintegrating Drug Products
Pp. 378-430 (53)
Vikas A. Saharan, Anupama Singh and Vandana Kharb
Websites of various drug regulatory agencies like US FDA, EMA, MHRA,
PMDA and CDSCO were visited and information about approval and market
authorisations of FDDF drug products’ was collected with an aim to provide updated
lists. Additionally, information about marketed FDDF drug products was also retrieved
from websites of pharmaceutical companies and other literature sources. This chapter
comprehensively enlists various drug products approved and marketed in US, UK,
Europe, Japan and India.
Bioequivalence, Brand, CDSCO, Controlled release, EMA, FDA,
Film, Generic, MDT, MHRA, Mouth dissolving, ODT, Orally disintegrating,
Orange book, Orodispersible, Patent, PMDA, Proprietary, Tablet.
Department of Pharmaceutics, School of Pharmaceutical Sciences, Sardar Bhagwan Singh Post Graduate Institute of Biomedical Sciences and Research, Balawala, Dehradun 248161, Uttarakhand, India.