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 | 248
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 | 249
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Appearance/organoleptic(odor, color
Page 198 and 199: Drug Registration Guidance Document
Page 214 and 215: ATTACHMENT 1Drug Registration Guida
Page 222 and 223: PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225: ATTACHMENT 2Drug Registration Guida
Page 230 and 231: APPENDIX 5:Drug Registration Guidan
Page 232 and 233: 1. GENERAL INFORMATIONSDrug Registr
Page 268 and 269: Route of AdministrationTAMC(CFU/g o
Page 276 and 277: d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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