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FDA Drug Application 020199 by ROCHE

Application Number020199
Application Type New Drug Application
Sponsor ApplicantROCHE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority*
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/19/1992N       
AP04/13/1994SCS       
AP010/7/1994SLR       
AP08/5/1994SE7       
AP010/7/1994SLR       
AP07/8/1994SCS       
AP03/4/1996SCS       
AP06/26/1996SE1       
AP010/4/1996SLR       
AP010/15/1997SCS       
AP03/4/1998SLR       
AP08/28/1998SLR       
AP04/19/2000SLR       
AP06/1/1999SLR       
AP07/3/2002SLR2221014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199s014ltr.pdf 7/3/2002
AP07/3/2002SLR2222014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s014lbl.pdf 7/3/2002
AP08/14/2002SLR2219015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20199slr015ltr.pdf 8/14/2002
AP08/14/2002SLR2220015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s15lbl.pdf 8/14/2002
AP09/12/2002SLR2217016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf 9/12/2002
AP09/12/2002SLR2218016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20199s16lbl.pdf 9/12/2002
AP08/2/2002SCS       




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