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FDA Drug Application 050162 by PHARMACIA AND UPJOHN

Application Number050162
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
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
AP02/22/1970N       
AP05/22/1970SE1       
AP07/1/1970SCS       
AP04/29/1983SCP       
AP09/10/1985SLR       
AP09/21/1970SCS       
AP06/21/1985SLR       
AP03/17/1997SLR       
AP010/20/1986SLR       
AP04/14/1988SE2       
AP04/26/1971SLR       
AP011/16/1970SLR       
AP012/9/1970SLR       
AP012/15/1970SLR       
AP012/18/1970SLR       
AP05/18/1971SLR       
AP03/17/1997SLR       
AP02/19/1971SLR       
AP02/21/1995SLR       
AP03/5/1993SCM       
AP03/17/1997SLR       
AP07/22/1971SLR       
AP02/15/1972SLR       
AP06/14/1971SCS       
AP09/22/1971SLR       
AP05/22/1972SCE       
AP02/15/1972SLR       
AP04/12/1972SLR       
AP05/11/1972SCS       
AP08/10/1972SLR       
AP07/14/1972SCS       
AP07/25/1972SLR       
AP01/12/1973SCS       
AP07/19/1973SLR       
AP04/3/1973SLR       
AP04/24/1974SLR       
AP04/24/1974SLR       
AP07/20/1973SCP       
AP010/16/1973SLR       
AP011/6/1973SCS       
AP08/16/1974SLR       
AP06/6/1974SCS       
AP08/9/1974SLR       
AP03/14/1975SLR       
AP03/17/1975SLR       
AP06/11/1975SLR       
AP011/17/1975SLR       
AP08/15/1977SLR       
AP01/28/1976SCS       
AP06/2/1976SCS       
AP07/2/1976SCS       
AP01/3/1977SLR       
AP02/14/1978SCS       
AP07/11/1978SLR       
AP06/28/1979SLR       
AP010/4/1978SLR       
AP04/24/1979SLR       
AP05/18/1979SCS       
AP07/9/1979SLR       
AP07/9/1979SLR       
AP07/20/1979SCM       
AP011/6/1979SLR       
AP04/30/1980SLR       
AP05/27/1980SCS       
AP05/20/1981SCS       
AP011/3/1981SE2       
AP04/27/1982SCF       
AP07/17/1997SLR       
AP012/12/1997SLR       
AP02/24/1998SCP       
AP09/29/2004SLR10357082   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162s082,50441s045,50639s013ltr.pdf 10/4/2004
AP09/29/2004SLR10358082   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/50162s082,50441s045,50639s013lbl.pdf 10/4/2004
AP011/15/1999SCP       
AP01/28/2004SLR7632084   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50162slr084,50441slr048,50639slr014ltr.pdf 2/2/2004
AP011/20/2009SLR24092085   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/050162s085lbl.pdf 11/23/2009
AP011/20/2009SLR24578085   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/050162s085ltr.pdf 1/21/2010
AP06/7/2011SLR29088090   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050162s090,050441s061,050639s022ltr.pdf 6/10/2011
AP06/26/2014SLR39671092   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093ltr.pdf 6/27/2014
AP06/26/2014SLR39693092   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf 6/30/2014
AP06/26/2014SLR39694093   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050162s092s093lbl.pdf 6/30/2014
AP06/26/2014SLR39672093   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050162Orig1s092,s093ltr.pdf 6/27/2014
AP01/21/2016SCM       
AP03/23/2016SLR45501095   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096ltr.pdf 3/25/2016
AP03/23/2016SLR45521095   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf 3/29/2016
AP03/23/2016SLR45522096   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s095s096lbl.pdf 3/29/2016
AP03/23/2016SLR45502096   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s095,s096ltr.pdf 3/25/2016
AP08/2/2016SLR46714097   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/050162Orig1s097ltr.pdf 8/3/2016
AP08/2/2016SLR46745097   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/050162s097lbl.pdf 8/9/2016




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