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FDA Drug Application 075049 by SANDOZ

Application Number075049
Application Type Abbreviated New Drug Application
Sponsor ApplicantSANDOZ
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
AP08/2/2001N9021000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Approv.pdf 6/4/2004
TA16/15/1999TA9021000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Approv.pdf 6/4/2004
TA24/30/2001TA9021000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Approv.pdf 6/4/2004
AP08/2/2001N9022000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Prntlbl.pdf 6/4/2004
TA16/15/1999TA9022000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Prntlbl.pdf 6/4/2004
TA24/30/2001TA9022000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75049_FLUOXETINE_Prntlbl.pdf 6/4/2004
AP08/2/2001N12437000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
TA16/15/1999TA12437000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
TA24/30/2001TA12437000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
AP08/2/2001N6330000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075049_fluoxetine_toc.cfm 8/4/2003
TA16/15/1999TA6330000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075049_fluoxetine_toc.cfm 8/4/2003
TA24/30/2001TA6330000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075049_fluoxetine_toc.cfm 8/4/2003
AP08/22/2001SL9020001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 6/4/2004
AP01/29/2002SCQ5101002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SL5102003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SCS5103004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SCF5104005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SCA5105007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SL5106008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SCS5107009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003
AP01/29/2002SL5108010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/75049s2ltr.pdf 4/9/2003




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