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FDA Drug Application 020864 by MERCK

Application Number020864
Application Type New Drug Application
Sponsor ApplicantMERCK
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/29/1998N431000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20864ltr.pdf 6/29/1998
AP06/29/1998N432000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20864-20865.cfm 4/8/1999
AP06/29/1998N433000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20864lbl.pdf 6/29/1998
AP06/29/1998N7164000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 12/12/2003
AP06/21/2000SE88350002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf 4/15/2004
AP011/16/1999SE83526003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20865S1LTR.PDF 12/30/1999
AP012/11/2000SLR8349004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-864S004_review.pdf 4/15/2004
AP012/11/2000SE88393005   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-005.pdf 4/21/2004
AP01/25/2001SCM       
AP012/11/2000SLR8391007   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20864S-007.pdf 4/21/2004
AP04/22/2002SLR3520008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20864s008.pdf 4/22/2002
AP04/22/2002SLR20437008   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020864_s008_MAXALT_TABLETS.pdf 8/1/2008
AP012/6/2001SCM       
AP012/16/2011SLR31151011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31097011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP08/12/2010SLR26215013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020864s013ltr.pdf 8/16/2010
AP08/12/2010SLR26246013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020864s013lbl.pdf 8/19/2010
AP012/16/2011SLR31098016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP012/16/2011SLR31152016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31153017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31099017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP012/16/2011SLR31100018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP012/16/2011SLR31154018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31155019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020864s011,s016,s017,s018,s019,020865s012,s016,s018,s020,s021ltr.pdf 12/21/2011
AP012/16/2011SLR31101019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020864s011s016s017s018s019,020865s012s016s018s020s021lbl.pdf 12/20/2011
AP05/29/2014SCM       
AP06/15/2015SCM       




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