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FDA Drug Application 019591 by ROCHE

Application Number019591
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/2/1989N2666000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf 10/4/2002
AP05/2/1989N23452000   http://www.fda.gov/downloads/Drugs/DrugSafety/ucm088616.pdf 9/25/2009
AP02/2/1990SLR       
AP07/30/1990SCS       
AP011/23/1992SE2       
AP010/4/1991SCS       
AP011/2/1993SLR       
AP011/3/1993SCS       
AP08/6/1997SLR       
AP06/16/1995SCM       
AP01/22/1996SCP       
AP08/2/1999SLR       
AP010/20/1998SCS       
AP08/2/1999SLR       
AP011/10/1999SCS       
AP01/10/2003SLR4210014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf 1/10/2003
AP01/10/2003SLR4759014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf 1/10/2003
AP03/24/2002SCS       
AP01/10/2003SLR4211017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/019591s014lbl.pdf 1/10/2003
AP01/10/2003SLR4760017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr014,017ltr.pdf 1/10/2003
AP06/21/2002SCS       
AP07/9/2003SLR6118019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591s19lbl_Lariam.pdf 7/9/2003
AP07/9/2003SLR6122019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr019ltr.pdf 7/10/2003
AP010/3/2002SLR6596020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/19591s20lbl.pdf 9/8/2003
AP08/20/2003SLR6594022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/19591slr022ltr.pdf 9/8/2003
AP08/20/2003SLR6595022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/19591slr022_lariam_lbl.pdf 9/8/2003
AP05/12/2008SLR19832023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s023ltr.pdf 5/14/2008
AP05/12/2008SLR19946023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s023lbl.pdf 6/5/2008
AP09/23/2008SLR20892024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf 9/26/2008
AP09/23/2008SLR20945024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf 10/3/2008
AP09/23/2008SLR20893025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/019591s024,019591s025ltr.pdf 9/26/2008
AP09/23/2008SLR20946025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/019591s024s025lbl.pdf 10/3/2008
AP08/20/2009SLR23377026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf 9/17/2009
AP08/20/2009SLR23963026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf 11/19/2009
AP06/26/2009SLR22852027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s027ltr.pdf 6/30/2009
AP06/26/2009SLR23075027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591slr027_lbl.pdf 7/24/2009
AP08/20/2009SLR23378028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/019591s026s028lbl.pdf 9/17/2009
AP08/20/2009SLR23964028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/019591s026,s028ltr.pdf 11/19/2009
AP04/29/2011SLR28689030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019591s030ltr.pdf 5/4/2011




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