DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SUBSTANCES97. NORFLOXACIN98. NORMAL GLOBULIN99. NOSCAPINE100. NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)101. OLANZAPINE102. PARACETAMOL103. PARACETAMOL WITH CAFFEINE IN COMBINATION104. PELARGONIUM SIDOIDES105. PENICILLIN106. PHENIRAMINE107. PHENYLEPHRINE108. PIRIBEDIL109. PIROXICAM110. PRAMIPEXOLE111. PROMETHAZINE HCL112. PROPAFENONE113. PROPOFOL114. PROPOLIS (TOPICAL)115. PROPYLTHIOURACIL116. PSEUDOEPHEDRINE117. PSYCHOTROPIC PRODUCTS118. QUETIAPINE119. QUINAGOLIDE120. RISPERIDONE121. ROPIRINOLENational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 348
Drug Registration Guidance Document (DRGD)NO.SUBSTANCES122. ROSIGLITAZONE123. ROYAL JELLY124. SALBUTAMOL125. SEDATIVE – HYPNOTIC PRODUCTS126. SELENIUM SULPHIDE127. SENNA LEAF (CASSIA) AND RHUBARB/ RADIX et RHIZOMA RHEI128. SODIUM METABISULPHITE (EXCIPIENT)129. SODIUM VALPROATE130. ST. JOHN‟S WORT (Hypericum perforatum)131. STATINS132. SULPHONAMIDES/ TRIMETHOPRIM133. TERBUTALINE134. TETRACYCLINE SYRUP135. THIOMERSAL136. THROMBOLYTIC AGENTS137. TIAPROFENIC ACID138. TRETINOIN (TOPICAL)139. TRIAZOLAM140. TRIPROLIDINE141. VARENICLINE142. VITAMIN K143. WARFARIN144. ZIPRASIDONE145. ZOLPIDEM TARTRATE146. ZOPICLONENational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 349
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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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Page 298 and 299: Drug Registration Guidance Document
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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