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FDA Drug Application 020520 by BOEHRINGER INGELHEIM

Application Number020520
Application Type New Drug Application
Sponsor ApplicantBOEHRINGER INGELHEIM
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
AP012/19/1995N       
AP06/8/1998SE1265001   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20520s1_Zantac.pdf 6/8/1998
AP03/26/1997SCP       
AP05/22/1998SCP       
AP012/8/1997SCM       
AP04/1/1998SCP       
AP02/28/2000SCM       
AP06/7/2000SCM       
AP011/8/2000SCM       
AP05/29/2001SLR       
AP05/30/2002SCM       
AP012/3/2002SCM       
AP02/28/2005SLR11192015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/20520s015ltr.pdf 3/3/2005
AP02/28/2005SLR19230015   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/020520_S015_ZANTAC.pdf 2/19/2008
AP07/25/2013SCM       
AP01/30/2015SLR41762028   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s028ltr.pdf 2/3/2015
AP01/30/2015SLR41862028   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s028lbl_corrected.pdf 2/17/2015
AP011/20/2015SLR44565030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020520Orig1s030ltr.pdf 11/23/2015
AP011/20/2015SLR44595030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020520Orig1s030lbl.pdf 11/25/2015
AP09/24/2015SCM       
AP01/26/2016SLR45177032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020520Orig1s032ltr.pdf 2/17/2016
AP01/26/2016SLR45232032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020520Orig1s032LBL.pdf 2/23/2016
AP07/27/2016SLR46675033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021698Orig1s023,020520Orig1s033ltr.pdf 7/28/2016
AP07/27/2016SLR46868033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021698Oirg1s023,020520Orig1s033lbl.pdf 8/23/2016




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