DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Common or Other NamesCocculus spp.CocculusCocculus carolinus (L.) DC.Syn. Cebatha carolina BrittonSyn. Epibaterium carolinum (L.) BrittonSyn. Menispermum carolinum L.Cocculus diversifolius DC.Syn. Cocculus madagascariensis DielsCocculus hirsutus (L.) DielsSyn. Cocculus villosus DC.Syn. Menispermum hirsutum L.Cocculus indicus RoyleSyn. Anamirta paniculata Colebr.Indian cockleCocculus laurifolius DC.Syn. Cinnamomum esquirolii H. Lév.Cocculus leaebe DC.Cocculus madagascariensis DielsSyn. Cocculus diversifolius DC.Cocculus orbiculatus DC.Syn. Cissampelos pareira Linn.Cocculus orbiculatus (L.) DC.Syn. Cocculus cuneatus Benth.Syn. Cocculus sarmentosus (Lour.) DielsSyn. Cocculus sarmentosus var. linearis Yamam.Syn. Cocculus sarmentosus var. pauciflorus Y.C. WuSyn. Cocculus sarmentosus var. stenophyllus Merr.Syn. Cocculus thunbergii DC.Moku-boui(Japanese)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 254
Drug Registration Guidance Document (<strong>DRGD</strong>)Botanical Name*Common or Other NamesSyn. Cocculus trilobus (Thunb.) DC.Syn. Menispermum orbiculatus L.Syn. Menispermum trilobum Thunb.Syn. Nephroia sarmentosa Lour.Cocculus palmatus (Lam.) DC.ColumbaColumboCocculus pendulus DielsSyn. Cebatha pendula (J.R. & C. Forst.) KuntzeSyn. Epibaterium pendulus Forst. f.Syn. Cocculus Epibaterium DC.Cocculus pendulus (Forst. & Forst.) DielsCocculus palmatus Hook.Syn. Jateorhiza Miersii OliverColomboCocculus thunbergii DC.Diploclisia affinis (Oliv.) DielsSyn. Diploclisia chinensis Merr.Syn. Cocculus affinis Oliv.Diploclisia chinensis MerrillXiangfangchiMenispernum dauricumSaussurea lappa (Decne.) Sch. Bip. / AucklandiaLappaMokkou (Japanese)National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 255
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Appearance/organoleptic(odor, color
Page 204 and 205: Drug Registration Guidance Document
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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