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FDA Drug Application 091052 by MYLAN PHARMS INC

Application Number091052
Application Type Abbreviated New Drug Application
Sponsor ApplicantMYLAN PHARMS INC
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
TA06/10/2011TA30098000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf 9/28/2011
AP12/8/2012N30098000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf 9/28/2011
TA06/10/2011TA32655000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091052Orig1s000Approv.pdf 5/9/2012
AP12/8/2012N32655000   http://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/091052Orig1s000Approv.pdf 5/9/2012
TA06/10/2011TA44403000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf 9/28/2011
AP12/8/2012N44403000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/091052s000ltr.pdf 9/28/2011




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