浙江省医院药事管理质控中心网-FDA今年8月批准药物品种

合理用药

不良反应

新药前沿

药物治疗

首页 >> 合理用药 >> 新药前沿

FDA今年8月批准药物品种

作者：时间：2009-08-25 点击：813 来源：网络来源

<TABLE cellSpacing=0 cellPadding=0 width=615 align=left border=1> <TBODY> <TR> <TD vAlign=top> <DIV align=center><STRONG><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=DrugName">Drug Name</A> <BR>and<A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=vwAllDrugs.ApplNo"><BR>FDA Appl. #</A> </STRONG></DIV></TD> <TD vAlign=top> <DIV align=center><STRONG><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=InDocTypeSeqNo"><BR>Suppl. #</A> </STRONG></DIV></TD> <TD vAlign=top> <DIV align=center><STRONG><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=ActiveIngred"><BR>Active<BR>Ingredients</A> </STRONG></DIV></TD> <TD vAlign=top> <DIV align=center><STRONG><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=SponsorApplicant"><BR>Company</A> </STRONG></DIV></TD> <TD vAlign=top> <DIV align=center><STRONG><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=DocTypeDesc"><BR>Approval<BR>Type</A> </STRONG></DIV></TD> <TD vAlign=top> <DIV align=center><STRONG><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.SetListOrder&ReturnFuseAction=Reports.MonthlyApprovalsAll&OrderBy=ActionDate"><BR>Approval<BR>Date</A> </STRONG></DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=076862&DrugName=METOPROLOL%20SUCCINATE&ActiveIngred=METOPROLOL%20SUCCINATE&SponsorApplicant=WATSON%20LABS%20FLORIDA&ProductMktStatus=1">METOPROLOL SUCCINATE<BR>(ANDA # 076862) </A></DIV></TD> <TD vAlign=top> <DIV align=center>000</DIV></TD> <TD vAlign=top> <DIV align=left>METOPROLOL SUCCINATE</DIV></TD> <TD vAlign=top> <DIV align=left>WATSON LABS FLORIDA</DIV></TD> <TD vAlign=top> <DIV align=left>Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/03/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=077118&DrugName=METOPROLOL%20SUCCINATE&ActiveIngred=METOPROLOL%20SUCCINATE&SponsorApplicant=WATSON%20LABS%20FLORIDA&ProductMktStatus=1">METOPROLOL SUCCINATE<BR>(ANDA # 077118) </A></DIV></TD> <TD vAlign=top> <DIV align=center>000</DIV></TD> <TD vAlign=top> <DIV align=left>METOPROLOL SUCCINATE</DIV></TD> <TD vAlign=top> <DIV align=left>WATSON LABS FLORIDA</DIV></TD> <TD vAlign=top> <DIV align=left>Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/03/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078621&DrugName=AZELASTINE%20HYDROCHLORIDE&ActiveIngred=AZELASTINE%20HYDROCHLORIDE&SponsorApplicant=APOTEX%20INC&ProductMktStatus=1">AZELASTINE HYDROCHLORIDE<BR>(ANDA # 078621) </A></DIV></TD> <TD vAlign=top> <DIV align=center>001</DIV></TD> <TD vAlign=top> <DIV align=left>AZELASTINE HYDROCHLORIDE</DIV></TD> <TD vAlign=top> <DIV align=left>APOTEX INC</DIV></TD> <TD vAlign=top> <DIV align=left>Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/03/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078700&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=TEVA%20PHARMS&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078700) </A></DIV></TD> <TD vAlign=top> <DIV align=center>000</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>TEVA PHARMS</DIV></TD> <TD vAlign=top> <DIV align=left>Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/03/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078817&DrugName=OXALIPLATIN&ActiveIngred=OXALIPLATIN&SponsorApplicant=SANDOZ&ProductMktStatus=4">OXALIPLATIN<BR>(ANDA # 078817) </A></DIV></TD> <TD vAlign=top> <DIV align=center>000</DIV></TD> <TD vAlign=top> <DIV align=left>OXALIPLATIN</DIV></TD> <TD vAlign=top> <DIV align=left>SANDOZ</DIV></TD> <TD vAlign=top> <DIV align=left>Tentative Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/03/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=090155&DrugName=EFAVIRENZ&ActiveIngred=EFAVIRENZ&SponsorApplicant=CIPLA%20LIMITED&ProductMktStatus=4">EFAVIRENZ<BR>(ANDA # 090155) </A></DIV></TD> <TD vAlign=top> <DIV align=center>000</DIV></TD> <TD vAlign=top> <DIV align=left>EFAVIRENZ</DIV></TD> <TD vAlign=top> <DIV align=left>CIPLA LIMITED</DIV></TD> <TD vAlign=top> <DIV align=left>Tentative Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/03/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=065440&DrugName=IDARUBICIN%20HYDROCHLORIDE&ActiveIngred=IDARUBICIN%20HYDROCHLORIDE&SponsorApplicant=APP%20PHARMS&ProductMktStatus=1">IDARUBICIN HYDROCHLORIDE<BR>(ANDA # 065440) </A></DIV></TD> <TD vAlign=top> <DIV align=center>000</DIV></TD> <TD vAlign=top> <DIV align=left>IDARUBICIN HYDROCHLORIDE</DIV></TD> <TD vAlign=top> <DIV align=left>APP PHARMS</DIV></TD> <TD vAlign=top> <DIV align=left>Approval</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078239&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=ZYDUS%20PHARMS%20USA%20INC&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078239) </A></DIV></TD> <TD vAlign=top> <DIV align=center>001</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>ZYDUS PHARMS USA INC</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078239&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=ZYDUS%20PHARMS%20USA%20INC&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078239) </A></DIV></TD> <TD vAlign=top> <DIV align=center>002</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>ZYDUS PHARMS USA INC</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078445&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=ANCHEN%20PHARMS&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078445) </A></DIV></TD> <TD vAlign=top> <DIV align=center>002</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>ANCHEN PHARMS</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078445&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=ANCHEN%20PHARMS&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078445) </A></DIV></TD> <TD vAlign=top> <DIV align=center>003</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>ANCHEN PHARMS</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078445&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=ANCHEN%20PHARMS&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078445) </A></DIV></TD> <TD vAlign=top> <DIV align=center>004</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>ANCHEN PHARMS</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078705&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=WOCKHARDT&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078705) </A></DIV></TD> <TD vAlign=top> <DIV align=center>001</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>WOCKHARDT</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078705&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=WOCKHARDT&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078705) </A></DIV></TD> <TD vAlign=top> <DIV align=center>002</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>WOCKHARDT</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078705&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=WOCKHARDT&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078705) </A></DIV></TD> <TD vAlign=top> <DIV align=center>003</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>WOCKHARDT</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD> <TD vAlign=top> <DIV align=left>08/04/2009</DIV></TD></TR> <TR> <TD vAlign=top> <DIV align=left><A href="http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Reports.Rpt_SetCurrentDrug&ApplNo=078791&DrugName=DIVALPROEX%20SODIUM&ActiveIngred=DIVALPROEX%20SODIUM&SponsorApplicant=IMPAX%20LABS&ProductMktStatus=1">DIVALPROEX SODIUM<BR>(ANDA # 078791) </A></DIV></TD> <TD vAlign=top> <DIV align=center>001</DIV></TD> <TD vAlign=top> <DIV align=left>DIVALPROEX SODIUM</DIV></TD> <TD vAlign=top> <DIV align=left>IMPAX LABS</DIV></TD> <TD vAlign=top> <DIV align=left>Supplement</DIV></TD></TR></TBODY></TABLE>

返回>>>