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FDA Drug Application 075465 by DR REDDYS LABS LTD

Application Number075465
Application Type Abbreviated New Drug Application
Sponsor ApplicantDR REDDYS LABS LTD
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
AP01/29/2002N6340000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075465_fluoxetine_toc.cfm 8/4/2003
TA16/26/2001TA6340000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/075465_fluoxetine_toc.cfm 8/4/2003
AP01/29/2002N9013000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Approv.pdf 6/4/2004
TA16/26/2001TA9013000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Approv.pdf 6/4/2004
AP01/29/2002N9014000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Prntlbl.pdf 6/4/2004
TA16/26/2001TA9014000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2002/75465_Fluoxetine_Prntlbl.pdf 6/4/2004
AP01/29/2002N9015000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75465ltr.pdf 6/4/2004
TA16/26/2001TA9015000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/75465ltr.pdf 6/4/2004
AP01/29/2002N12448000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005
TA16/26/2001TA12448000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm109352.htm 8/1/2005




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