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FDA Drug Application 012945 by TEVA BRANDED PHARM

Application Number012945
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
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
AP04/25/1995SCF       
AP09/27/1999SCS       
AP03/15/2005SCM41705037   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/012945Orig1s037.pdf 1/28/2015
AP03/15/2005SCM11263037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf 3/18/2005
AP03/15/2005SCM11267037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf 3/18/2005
AP03/15/2005SLR11268038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/12945s037,038lbl.pdf 3/18/2005
AP03/15/2005SLR41704038   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/012945Orig1s038.pdf 1/28/2015
AP03/15/2005SLR11264038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/12945s037,038ltr.pdf 3/18/2005
AP03/19/2014SCM       
AP04/9/2014SCM       




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