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FDA Drug Application 021341 by GD SEARLE

Application Number021341
Application Type New Drug Application
Sponsor ApplicantGD SEARLE
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
AP011/16/2001N4414000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-341_Bextra_Approv.pdf 11/16/2001
AP011/16/2001N4415000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21341lbl.pdf 11/16/2001
AP011/16/2001N4416000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-341_Bextra.cfm 5/30/2002
AP011/16/2001N7097000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm 12/9/2003
AP011/1/2002SLR4417002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21341slr002ltr.pdf 11/1/2002
AP011/1/2002SLR15643002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/021341_S002_BEXTRATOC.cfml 1/10/2007
AP04/23/2004SE88411003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341se8-003ltr.pdf 4/29/2004
AP04/23/2004SE88502003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341se8-003_bextra_lbl.pdf 5/4/2004
AP011/24/2004SLR10672006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21341ltr.pdf 12/2/2004
AP011/24/2004SLR10718006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21341lbl.pdf 12/3/2004




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