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FDA Drug Application 075135 by UPSHER SMITH

Application Number075135
Application Type Abbreviated New Drug Application
Sponsor ApplicantUPSHER SMITH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type
Therapeutic Potential
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/30/1998N446000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135.cfm 5/28/1999
AP04/30/1998N4981000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf 4/30/1998
AP04/30/1998N4982000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135ap_appltr_prntlbl_chemr.pdf 4/30/1998
AP04/30/1998N12475000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm118073.htm 8/1/2005
AP04/30/1998N24043000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088668.pdf 11/20/2009
AP012/2/1999SC4389001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s001ltr.pdf 4/30/1998
AP012/2/1999SC4614001   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP012/2/1999SCB4615002   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP012/2/1999SCB4390002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s002ltr.pdf 12/2/1999
AP09/24/1999SL3108003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/75135s003ltr.pdf 9/24/1999
AP09/24/1999SL4616003   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP02/1/2000SB4617004   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP02/1/2000SB4388004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/75135s004ltr.pdf 2/1/2000
AP04/12/2000SCB463900510/29/02  http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP04/12/2000SCR4640006   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP04/12/2000SL4641007   http://www.accessdata.fda.gov/drugsatfda_docs/anda/98/75135s001-007_Pacerone.pdf 10/29/2002
AP08/20/2002SL       
AP012/19/2002SCB       




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