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FDA Drug Application 040350 by MYLAN

Application Number040350
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
AP03/29/2000N1149000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/40350ltr.pdf 3/29/2000
AP03/29/2000N12123000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/040350.pdf 7/22/2005
AP06/7/2001SCQ12100001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf 7/22/2005
AP06/7/2001SCS12101002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf 7/22/2005
AP06/7/2001SCA12102003   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/040350s001s002s003.pdf 7/22/2005
AP06/7/2001SL       
AP07/10/2001SCS       
AP09/28/2001SCP       
AP07/12/2012SLR43656016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/040350s016lbl.pdf 8/14/2015




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