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FDA Drug Application 075755 by MYLAN

Application Number075755
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN
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
AP08/2/2001N1865000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75755ltr.pdf 8/2/2001
AP08/2/2001N6343000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075755_fluoxetine_toc.cfm 8/4/2003
AP08/2/2001N9029000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf 6/4/2004
AP08/2/2001N12456000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
TA16/29/2001TA1865000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75755ltr.pdf 8/2/2001
TA16/29/2001TA6343000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/075755_fluoxetine_toc.cfm 8/4/2003
TA16/29/2001TA9029000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2001/75755_Prozac_Prntlbl.pdf 6/4/2004
TA16/29/2001TA12456000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
AP05/3/2002SCS       
AP011/17/2014SLR43752021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/075755s021lbl.pdf 8/31/2015




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