DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SUBSTANCES47. DICLOFENAC SODIUM48. DICYCLOMINE49. DIPHENHYDRAMINE50. DIPHENOXYLATE51. DOPAMINERGIC INGREDIENT52. EPHEDRINE53. FAMOTIDINE54. FIBRATES55. FLUCLOXACILLIN56. FLUORIDE57. FLUOROQUINOLONES58. FLURAZEPAM HYDROCHLORIDE59. GADOBENIC ACID60. GADOBUTROL61. GADODIAMIDE62. GADOLINIUM OXIDE63. GADOTERIC ACID64. GADOVERSETAMIDE65. GADOXETIC ACID66.GADOLINIUM BASED CONTRAST MEDIUM FOR MAGNETICRESONANCE IMAGING67. GENTAMICIN TOPICAL PREPARATIONS68. GINKGO BILOBA/ GINKGO EXTRACT69. GINSENG70. GLUCOSAMINE71. HIV PROTEASE INHIBITORSNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 346
Drug Registration Guidance Document (<strong>DRGD</strong>)NO.SUBSTANCES72. HYDROQUINONE73. IMMUNOSUPPRESANTS74. INSULIN75. INGREDIENTS DERIVED FROM SEAFOOD76. KAOLIN, PECTIN, KAOLIN-PECTIN77. KETOCONAZOLE78. KETOROLAC TROMETHAMOL (KETOROLAC TROMETHAMINE)79. LEVODOPA80. LINCOMYCIN81. LISURIDE82. LIQUID PARAFFIN83. LOPERAMIDE84. LORATADINE85. LORAZEPAM86. METHYL SALICYLATE87. METHYLPHENIDATE HCL88. METOCLOPRAMIDE89. MICONAZOLE90. MIDAZOLAM91. MINOXIDIL92. MUCOLYTIC AGENT93. NEVIRAPINE94. NIFEDIPINE95. NITRATES96. NITRAZEPAMNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 347
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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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d) Example of label approved by the
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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