Back to FDA Applications sponsored by GLAXOSMITHKLINE CON

FDA Drug Application 017874 by GLAXOSMITHKLINE CON

Application Number017874
Application Type New Drug Application
Sponsor ApplicantGLAXOSMITHKLINE CON
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
AP012/31/1979N       
AP01/28/1980SCE       
AP04/10/1981SCM       
AP02/9/1981SCE       
AP010/27/1981SLR       
AP011/2/1981SCS       
AP06/2/1982SCS       
AP07/25/1984SCM       
AP03/17/1988SCS       
AP010/3/1988SCM       
AP07/26/2001SLR4019018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf 7/26/2001
AP07/26/2001SLR5162018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf 4/10/2003
AP07/26/2001SLR17172018   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018 & S027_SCOPOLAMINE_AP.pdf 7/9/2007
AP07/10/1990SCP       
AP03/5/1992SCM       
AP06/28/1993SCM       
AP02/10/1993SCM       
AP05/31/1994SCS       
AP07/26/2001SLR4020027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/17874s18s27ltr.pdf 7/26/2001
AP07/26/2001SLR5213027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/017874s18s27lbl.pdf 4/11/2003
AP07/26/2001SLR17173027   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/017874_S018 & S027_SCOPOLAMINE_AP.pdf 7/9/2007
AP010/7/1996SCS       
AP06/19/1998SCM       
AP05/30/2000SCM       
AP03/22/2002SLR4018032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/17874s032ltr.pdf 3/22/2002
AP01/10/2007SLR15669035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/017874s035_ltr.pdf 1/16/2007
AP04/30/2013SLR35923038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017874Orig1s038ltr.pdf 5/2/2013
AP04/30/2013SLR36163038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017874s038lbl.pdf 5/30/2013
AP05/15/2013SCM       




Back to FDA Applications sponsored by GLAXOSMITHKLINE CON