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FDA Drug Application 011839 by PHARMACIA AND UPJOHN

Application Number011839
Application Type New Drug Application
Sponsor ApplicantPHARMACIA AND UPJOHN
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/18/1959N       
AP010/4/1973SCS       
AP010/21/1975SOA       
AP06/6/1979SES       
AP07/23/1979SES       
AP011/1/1985SCF       
AP010/26/1987SLR       
AP06/3/1988SCM       
AP010/6/1989SCM       
AP012/18/1991SLR       
AP06/19/1992SCS       
AP011/19/1991SLR       
AP06/23/1993SCS       
AP04/30/1993SLR       
AP06/23/1993SCP       
AP011/28/1995SCS       
AP03/31/1998SLR       
AP08/4/1998SE1540068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/11839S68LTR.PDF 8/4/1998
AP08/4/1998SE14190068   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/11839-S068_Provera.pdf 8/4/1998
AP09/28/2007SLR18130071   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/011839s071ltr.pdf 10/4/2007
AP09/28/2007SLR18169071   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/011839s071lbl.pdf 10/4/2007
AP05/7/2015SLR42755079   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf 5/8/2015
AP05/7/2015SLR42765079   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080ltr.pdf 5/11/2015
AP05/7/2015SLR42766080   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/011839Orig1s079,s080ltr.pdf 5/11/2015
AP05/7/2015SLR42756080   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/011839s079s080lbl.pdf 5/8/2015




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