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FDA Drug Application 020746 by ASTRAZENECA PHARMS

Application Number020746
Application Type New Drug Application
Sponsor ApplicantASTRAZENECA PHARMS
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
AP010/1/1999N177000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20746ltr.pdf 10/1/1999
AP010/1/1999N178000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20746lbl.pdf 10/1/1999
AP010/1/1999N9387000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20746_Rhinocort.cfm 6/16/2004
AP09/25/2000SCM       
AP06/25/2001SCS       
AP010/26/2001SE83210004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20746s4ltr.pdf 10/26/2001
AP06/18/2001SCS       
AP05/18/2001SCS       
AP05/31/2002SCS       
AP010/3/2002SCM       
AP09/26/2003SLR6719011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20441slr018,20746slr011,20929slr015_pulmicort_lbl.pdf 9/30/2003
AP09/26/2003SLR6721011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20441slr018,20746slr011,20929slr015ltr.pdf 9/26/2003
AP01/16/2004SLR7590013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746slr013ltr.pdf 1/22/2004
AP01/16/2004SLR7614013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746slr013_rhinocort_lbl.pdf 1/22/2004
AP08/25/2004SLR10102015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s015ltr.pdf 8/31/2004
AP08/25/2004SLR10103015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20746s015lbl.pdf 8/31/2004
AP07/30/2004SE89927016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20746s016ltr.pdf 8/2/2004
AP010/16/2007SLR18261021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/020746s021lbl.pdf 10/22/2007
AP010/16/2007SLR18282021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020746s021ltr.pdf 10/22/2007
AP05/21/2009SLR22603024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020746s024lbl.pdf 5/25/2009
AP05/21/2009SLR22651024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/020746s024ltr.pdf 5/29/2009
AP012/28/2010SLR27440026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020746s026lbl.pdf 12/28/2010
AP012/28/2010SLR27442026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020746s026ltr.pdf 1/4/2011
AP04/29/2013SCM       
AP03/23/2015SE642262032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020746Orig1s032ltr.pdf 3/25/2015
AP03/23/2015SE642278032   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020746Orig1s032.pdf 3/25/2015
AP03/10/2016SLR45426033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s033ltr.pdf 3/14/2016
AP03/10/2016SLR45447033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s033lbl.pdf 3/15/2016
AP04/22/2016SLR45738034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s034ltr.pdf 4/25/2016
AP04/22/2016SLR45835034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s034lbl.pdf 5/3/2016
AP03/2/2016SCM       
AP08/24/2016SLR46898036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020746Orig1s036ltr.pdf 8/29/2016
AP08/24/2016SLR46916036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020746Orig1s036lbl.pdf 8/30/2016




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