DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.16.17.18.19.20.21.22.23.24.25.26.27.28.COLOURING AGENTSDibromofluorescein/ D & C Orange No. 5(mouth wash, dentifrices, external use only)Diiodofluorescein/ D & C Orange No. 10(external use only)D & C Orange No. 11(external use only)Ponceau SX/ FD & C Red No. 4(external use only)Lithol Rubin B/ D & C Red No. 6(may be use in combination; total not more than 5mg/day)Lithol Rubin B CA/ D & C Red No. 7(may be used in combination; total not more than 5mg/day)D & C Red No. 31(external use only)Deep Maroon/ D & C Red No. 34(external use only)D & C Red No. 39(external use only, not more than 0.1%)Uranine Acid Form/ D & C Yellow No. 7(external use only)EXT. D & C Yellow No. 7(external use only)Uranine Sodium Salt/ D & C Yellow No. 8(external use only)Tartrazine/ FD & C Yellow No. 5/MA Yellow A-2/ Aluminic Lake(external use only)COLOURINDEXNUMBER (CI)4537045425147001585015850:115880:145350:14535019140National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 342
Drug Registration Guidance Document (<strong>DRGD</strong>)APPENDIX 9:LABELLING REQUIREMENTSThis appendix comprises of two (2) parts:a) General Labelling Requirements for:i) Section D : Label (Mock-Up) for Immediate Container and Outer Cartonii) Section Diii) Section E8/ F8: Proposed Package Insert (PI): Patient Information Leaflet (PIL)b) Specific Labelling RequirementsNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 343
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ATTACHMENT 1Drug Registration Guida
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PART IV: CLINICAL DOCUMENTSDrug Reg
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ATTACHMENT 2Drug Registration Guida
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APPENDIX 5:Drug Registration Guidan
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1. GENERAL INFORMATIONSDrug Registr
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Route of AdministrationTAMC(CFU/g o
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e) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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