DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)(Source for Lists A and B)U. S. Food and Drug AdministrationCenter for Food Safety and Applied NutritionOffice of Nutritional Products, Labeling, andHealth Supplements[Revised April 9, 2001]List A: Botanicals Known or Suspected to Contain Aristolochic AcidTable 3:Asarum canadense Linn.Botanical Name*Syn. Asarum acuminatum (Ashe) E.P. BicknellSyn. Asarum ambiguum (E.P. Bicknell) DanielsSyn. Asarum canadense var. ambiguum (E.P.Bicknell) Farw.Syn. Asarum canadense var. reflexum (E.P. Bicknell)B.L.Rob.Syn. Asarum furcatum Raf.Syn. Asarum medium Raf.Syn. Asarum parvifolium Raf.Syn. Asarum reflexum E.P. BicknellSyn. Asarum rubrocinctum PeattieAsarum himalaicum Hook. f. & Thomson ex KlotzschorAsarum himalaycum Hook. f. & Thomson exKlotzschAsarum splendens (F. Maek.) C.Y. Cheng & C.S.YangCommon or Other NamesWild gingerIndian gingerCanadasnakerootFalse coltsfootColic rootHeart snakerootVermontsnakerootSouthernsnakerootTanyou-saishin(Japanese)Do-saishin(Japanese)Bragantia wallichii R.Br.Specimen exists at New York Botanical Gardens.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 250
Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Common or Other NamesTropicosdoes not list this species as a synonym for anyThotteaspecies. Kew Gardens Herbarium does notrecognize thegenera Bragantia. Until additional information isobtained wewill use the name as cited in J. Nat. Products45:657-666(1982)List B: Botanicals which may be Adulterated with Aristolochic AcidTable 4:Botanical Name*Common or Other NamesAkebia spp.Akebia quinata (Houtt.) Decne.Syn. Rajania quinata Houtt.AkebiaMu tongKu mu tongZi mutongBai mu tongMokutsu (Japanese)Mokt'ong (KoreanChocolate vineFiveleaf akebiaMu tongYu zhi ziMokutsu (Japanese)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 251
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Page 200 and 201: Drug Registration Guidance Document
Page 202 and 203: Appearance/organoleptic(odor, color
Page 220 and 221: ATTACHMENT 1Drug Registration Guida
Page 228 and 229: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231: ATTACHMENT 2Drug Registration Guida
Page 236 and 237: APPENDIX 5:Drug Registration Guidan
Page 238 and 239: 1. GENERAL INFORMATIONSDrug Registr
Page 274 and 275: Route of AdministrationTAMC(CFU/g o
Page 282 and 283: e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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