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FDA Drug Application 076885 by MYLAN PHARMS INC

Application Number076885
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
TA01/17/2006TA13472000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76885TAltr.pdf 1/20/2006
AP111/8/2013N13472000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/76885TAltr.pdf 1/20/2006
TA01/17/2006TA37799000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076885Orig1s000ltr.pdf 11/13/2013
AP111/8/2013N37799000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/076885Orig1s000ltr.pdf 11/13/2013
TA01/17/2006TA37849000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076885Orig1s000lbl.pdf 11/19/2013
AP111/8/2013N37849000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/076885Orig1s000lbl.pdf 11/19/2013




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