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95S-0316: 75-Day Premarket Notifications for New Dietary Ingredients


Document # Received Date Filed Date Submitter Code Submitter FR Date FR Page Comment Date Files Remarks
 
RPT170 01/08/2004 01/08/2004 Dietary Supplement Industry
Biodynamics (Distributor)       Part 1
Part 2
[Desmondium adscendens D.C. (overground stems)]
Signature: Biodynamics (Distributor)
RPT171 11/20/2003 11/20/2003 Dietary Supplement Industry
Kups International       pdf Lactobacillus plantarum and Fructoooligosaccharides (FOS)(Gastroplan and Gastroplan CF)
Signature: Kups International
RPT172 01/08/2004 11/13/2003 Dietary Supplement Industry
PhytoMedica, LLC       Submission
Tab 1
Tab 2
Tab 3
Tab 4
Tab 5
Tab 6
Tab 7
Copyrighted materials
Extract of Chrysanthellum americanurn (L.) Vatke
Signature: PhytoMedica, LLC
RPT173 01/08/2004 11/13/2003 Dietary Supplement Industry
Care & Health Limited       pdf Ganoderma Lucidum Spore Powder [Lingzhi Master Brand]
Signature: Care & Health Limited
RPT174 01/08/2004 11/19/2003 Private Industry EGN Pharma, Inc      

Part 1
Ingredients
Indications & Dosage
History of Use
Labels
Contact Information

Copyrighted materials

Fitovit (An Herbal Dietary Supplement)
Signature: EGN Pharma, Inc
RPT175 01/29/2004 11/19/2003 International MicroBio Co., LTD       pdf
Appendix A
Appendix B
Appendix C
Appendix D
Appendix E Part 1
Appendix E Part 2
N K Activator
Signature: MicroBio Co., LTD
RPT176 01/28/2004 11/19/2003 Private Industry Kyowa Hakko USA Inc      

Part 1 pdf

Part 2 pdf

Copyrighted materials

N-Acetyl-L-Hydroxyproline (AHYP)
Signature: Kyowa Hakko USA Inc
RPT177 01/16/2004 05/26/2003 Private Industry Hi Tech Pharma Inc      

pdf

Copyrighted materials

Cumaris (Powdered Exts of Rhizoma Chuanxiong, Radix Angelicae Dahuricae and Imperatorin)
Signature: Hi Tech Pharma Inc
RPT178 01/16/2004 05/27/2003 Private Industry Exceeding Corp.       pdf Tsygapan
Signature: Exceeding Corp.
RPT179 01/16/2004 08/10/2003 Private Industry BSP Pharm A/S      

pdf

Copyrighted materials

BSP-201, Shea Nature
Signature: David H Bechtel PhD, CANTOX
RPT180 01/16/2004 05/27/2003 Private Industry Cyber Store LLC       pdf Sanqi, Panax notoginseng
Signature: Yao Huang
RPT181 01/16/2004 05/29/2003 International Advanced Orthomolecular Research      

pdf

Copyrighted materials

benfotiamin
Signature: Dr Traj Nibber
RPT182 01/16/2004 06/14/2003 Private Industry Amino GmbH      

pdf

Tab 1

Tab 2

Tab 3

Copyrighted materials

Uridine
 
 
Signature: Diane B McColl, Jennifer B Davis
RPT183 01/16/2004 06/19/2003 International Hormo Nutraceutical Oy Ltd       pdf 7-hydroxymatairesinol (HMR) potassium acetate complex
Signature: Lars Pellas
RPT184 01/16/2004 06/17/2003 Individual Consumer Mark Weiner       pdf Guatteria gaumeri (Yumel)
Signature: Mark Weiner
RPT185 01/28/2004 06/23/2003 Private Industry Atlantic Medical Health Care, Inc. (Distributor)       pdf Ganoderma lucidum capsules
Signature: Ming Li
RPT186 01/16/2004 07/04/2003 Private Industry Goen Group      

pdf

Copyrighted materials

Hoodia gordonii
Signature: Ralph Fucetola JD
RPT187 01/16/2004 07/11/2003 Private Industry Co-Creations       pdf Bactris Balanoidea
Signature: Kimberly Hudson

 

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Page last updated January 18, 2005


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