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FDA Drug Application 020394 by BOEHRINGER INGELHEIM

Application Number020394
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/20/1995N       
AP011/9/1998SE1711001   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20394s01ltr.pdf 11/9/1998
AP011/9/1998SE1712001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20394-S001_Atrovent.pdf 11/9/1998
AP01/27/2000SCM       
AP08/18/1999SCS       
AP010/27/2000SE130806004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394 Orig1s004.pdf 10/27/2000
AP010/27/2000SE131013004Approval PAckage  http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/020394Orig1s004.pdf 12/16/2011
AP05/23/2003SLR5747005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20393slr004,20394slr005ltr.pdf 5/30/2003
AP05/23/2003SLR10232005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/020394s005lbl.pdf 9/20/2004
AP010/14/2008SLR21035008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020394s008ltr.pdf 10/21/2008
AP02/18/2011SLR27966012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020394s012ltr.pdf 2/24/2011




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