FDA Logo links to FDA home page Skip Navigation
U.S. Food and Drug Administration
HHS Logo links to Department of Health and Human Services website
horizonal rule
Dockets Management

Back


1995S-0316
RPT 356
Volume 279

Cover page, Letter from CFSAN to Iwade Research Institute of Mycology Co., Ltd.

75-Day Notification for New Dietary Ingredient ABM-FD

References

Tab 1 - Manufacturing Information - Redacted

Tab 2 - ABM-FD: Toxicity Study by Oral Gavage Administration to CD Rats for 13 weeks. Huntington Life Sciences, part 2, part 3, part 4, part 5, part 6

Tab 3 - ABM-FD (EXTRACT OF HIMEMATSUTAKE): Bacterial Reverse Mutation Test. Huntingdon Life Sciences

Tab 4 - ABM-FD (EXTRACT OF HIMEMATSUTAKE): In Vitro Mutation Test Using Mouse Lymphoma L5178Y Cells. Huntingdon Life Sciences

Tab 5 - ABM-FD (EXTRACT OF HIMEMATSUTAKE): Rat Micronucleus Test. Huntingdon Life Sciences

Tab 6 - The Safety of Extended Consumption of Freeze-Dry of Agaricus blazei Murrill (Iwade strain 101) Himenatsutake Extracts. Osami Kajimoto, Yutaka Ikeda, Mitsuharu Tabune, Akane Sakamoto, Yoshitaka Kajimoto Published Material

Tab 7 - Lack of a subchronic toxicity of an aqueous extract of Agaricus blazei Murrill in F344 rats. Y. Kuroiwa, et al.: Food and Chemical Toxicology 43, 1047-1053, 2005. Published Material


Top | Back

Page last updated November 20, 2006 RSChorizonal rule
Dockets Home Page | Dockets Contacts and Location | Operating Status | Item Code Definitions | Federal Register
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

FDA/Dockets Management