1995S-0316
RPT 251
Volume 183

Cover Page

Letter from CFSAN to Law Offices of Runan Zhang

Premarket Notification for “Shuanghuanglian - Healthy Respiration,” English description: Extract of Honeysuckle, Forsythia & Root of Skullcap

Tab 1 - Translated Certificate of New Herbal Medicine and Approval for Manufacture of Shuanghuanglian Powder by China Health Ministry, 1993, attached with Chinese document

Tab 2 - Translated Certificate of New Herbal Medicine and Approval for Manufacture of Shuanghuanglian Powder Injection by China Health Ministry, 1993, attached with Chinese document

Tab 3 - Translation of Chinese medicine dictionary on Shuanghuanglian Powder, the product will be marketed here with the name of Shuanghuanglian - Healthy Respiration, attached with Chinese document

Tab 4 - Introduction of Shuanghuanglian Powder

Tab 5 - Copy of translated Rencao Gangmu (Guideline of Herbs) on three new ingredient herbs, attached with the copy of Chinese book published about 800 year ago

Tab 6 - Copy of translated Shennong Bebcao Jing (Collection of Herbs) on three new ingredient herbs, attached with the copy of Chinese book published about 500 years ago

Tab 7 - Translation of Chinese Herbs 2000 edition on three new ingredient herbs, attached with the copy of Chinese book

Tab 8 - Translation of Modern Study of the Medical Formulae of Traditional Chinese Medicine on Shuanghuanglian Injection Liquid attached with the copy of Chinese book

Tab 9 - Data of Experiment on Acute Toxicity of Shuanghuanglian Oral Liquid

Tab 10 - The Brief Introduction of Research Institute which conducted the experiment

Tab 11 - Study on the Shuanghuanglian Powder [injection] prepared by the manufacturer on the related data and information concerning its use and medical function

Tab 12 - Article entitled Study on Antivirus Effect of Shuanghuanglian Injection published in Chinese Traditional and Herbal Drugs in 2002

Tab 13 - Article entitled Effects of Shuanghuanglian Treatment of Child Pneumonia published in Chinese Journal of Integrated Traditional and Western Medicine in 1994

Tab 14 - Article entitled Clinical Observation of Shuanghuanglian in Treating Late Term Malirmant Cancer with Complication of Lune Infection published in the Practical Journal of Integrating Chinese with Modern Medicine in 1998

Tab 15 - Article entitled Clinical Observation on Treatment of Child Pneumonia by Shuanghuanglian published in Shanghai Journal of Traditional Chinese Medicine in 1994

Tab 16 - Article entitled Clinical Observation of Treatment be Shuanghuanglian of 125 Cases of Child Upper Respiratory Tract Infection in Lishizhen Medicien and Materia Medica Research in 1999

Tab 17 - Article entitled CASE STUDY: Clinical Observations of Treating 140 Child Infectious Disease with Shuanghuanglian published in Chinese Journal of Hospital Pharmacy in 1998

Tab 18 - Article entitled 80 CASES OF MINISTERING SHUANGHUANGLIAN INTECTION IN TREATMENT OF PEDIATRIC RESPIRATORY TRACT INFECTION published in Shanxi Journal of Chinese Traditional Medicine in 1993

Tab 19 - Certificate of Good Manufacturing Practices (GMP) for Human Drugs People’s Republic of China for the manufacturer of the proposed dietary supplement

Tab 20 - List of US patents concerning the three new ingredient herbs used for different functions

Tab 21 - Copy of the English book on the three herbs