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FDA Drug Application 020788 by MERCK

Application Number020788
Application Type New Drug Application
Sponsor ApplicantMERCK
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
AP012/19/1997N6424000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020788_propecia_toc.cfm 8/7/2003
AP012/19/1997N31029000   http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm258424.htm 12/20/2011
AP011/3/1998SCS       
AP010/21/2004SLR10484002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf 10/29/2004
AP010/21/2004SLR10514002   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf 11/1/2004
AP012/8/2001SLR5444003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20788s3lbl.pdf 4/24/2003
AP04/10/2002SLR3952004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf 4/10/2002
AP04/10/2002SLR3953004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf 4/10/2002
AP04/10/2002SLR3954005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf 4/10/2002
AP04/10/2002SLR3955005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf 4/10/2002
AP07/18/2000SCE       
AP04/10/2002SE83956007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20788s4s5s7ltr.pdf 4/10/2002
AP04/10/2002SE83957007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20788S4lbl.pdf 4/10/2002
AP010/30/2002SCS       
AP010/21/2004SLR10485010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf 10/29/2004
AP010/21/2004SLR10515010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf 11/1/2004
AP010/21/2004SLR10516011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20788s002,010,011lbl.pdf 11/1/2004
AP010/21/2004SLR10486011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20788s002,010,011ltr.pdf 10/29/2004
AP03/24/2010SLR25125015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020788s015lbl.pdf 3/26/2010
AP03/24/2010SLR25134015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020788s015ltr.pdf 3/29/2010
AP06/10/2011SLR29220016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/019558s053plus15othersltr.pdf 6/17/2011
AP03/11/2011SLR39731017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s017.pdf 7/2/2014
AP03/11/2011SLR28240017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s017lbl.pdf 3/14/2011
AP03/11/2011SLR28255017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s017ltr.pdf 3/16/2011
AP04/13/2011SLR28557018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788s018lbl.pdf 4/15/2011
AP04/13/2011SLR28569018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s018ltr.pdf 4/19/2011
AP04/13/2011SLR38290018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/020788Orig1s018.pdf 1/16/2014
AP04/11/2012SLR39726020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s020.pdf 7/2/2014
AP04/11/2012SLR32416020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf 4/12/2012
AP04/11/2012SLR32391020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf 4/11/2012
AP04/11/2012SLR32392021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf 4/11/2012
AP04/11/2012SLR32417021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf 4/12/2012
AP04/11/2012SLR39732021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s021.pdf 7/2/2014
AP06/9/2011SLR29097022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/020788Orig1s022lbl.pdf 6/10/2011
AP06/9/2011SLR29111022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/020788s022ltr.pdf 6/13/2011
AP04/11/2012SLR39733023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2012/020788Orig1s023.pdf 7/2/2014
AP04/11/2012SLR32418023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020788s020,s021,s023ltr.pdf 4/12/2012
AP04/11/2012SLR32393023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020788s020s021s023lbl.pdf 4/11/2012
AP01/31/2014SLR38427024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020788s024lbl.pdf 2/3/2014
AP01/31/2014SLR38440024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020788Orig1s024ltr.pdf 2/4/2014
AP01/11/2016SCM       




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