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FDA Drug Application 020865 by MERCK

Application Number020865
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/29/1998N3522000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf 6/29/1998
AP06/29/1998N3523000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf 6/29/1998
AP06/29/1998N3524000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.cfm 4/8/1999
AP06/29/1998N7166000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 12/12/2003
AP011/16/1999SE83525001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF 11/23/1999
AP06/21/2000S8392002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-865S002_review.pdf 4/21/2004
AP03/28/2000SCS       
AP06/21/2000SE89198004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf 6/9/2004
AP012/11/2000SLR8394005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-005.pdf 4/21/2004
AP012/11/2000SE88389006   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-006.pdf 4/21/2004
AP012/11/2000SLR8388007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20865S-007.pdf 4/21/2004
AP03/23/2001SCM       
AP04/22/2002SLR3521009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf 4/22/2002
AP04/22/2002SLR20436009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020865_s009_MAXALT_TABLETS.pdf 8/1/2008
AP012/6/2001SCM       
AP012/16/2011SLR31156012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31091012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP08/12/2010SLR26216014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020865s014ltr.pdf 8/16/2010
AP08/12/2010SLR26247014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020865s014lbl.pdf 8/19/2010
AP012/16/2011SLR31092016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP012/16/2011SLR31157016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31158018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31093018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP012/16/2011SE831094020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP012/16/2011SE831159020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31160021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31095021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP05/29/2014SCM       




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