Back to FDA Applications sponsored by HOSPIRA

FDA Drug Application 021038 by HOSPIRA

Application Number021038
Application Type New Drug Application
Sponsor ApplicantHOSPIRA
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
AP012/17/1999N996000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/21038ltr.pdf 12/17/1999
AP012/17/1999N997000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/21038lbl.pdf 12/17/1999
AP012/17/1999N3679000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/21-038_Precedex.cfm 12/17/1999
AP01/16/2001SLR       
AP05/8/2001SCS       
AP010/17/2008SE121036010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021038s010ltr.pdf 10/21/2008
AP04/18/2014SCM       
AP010/13/2010SLR26681017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/021038s017ltr.pdf 10/19/2010
AP010/13/2010SLR26701017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/021038s017lbl.pdf 10/19/2010
AP010/13/2010SLR37480017   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2010/021038Orig1s017.pdf 10/21/2013
AP011/14/2014SLR41044019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf 11/20/2014
AP011/14/2014SLR41121019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf 12/1/2014
AP03/13/2013SCM35479020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s020lbl.pdf 3/19/2013
AP03/13/2013SCM43425020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2013/021038Orig1s020.pdf 7/21/2015
AP06/17/2013S36323021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s021lbl.pdf 6/17/2013
AP06/17/2013S36336021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022ltr.pdf 6/18/2013
AP06/17/2013S36322022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021038s022lbl.pdf 6/17/2013
AP06/17/2013S36337022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021038Orig1s021,s022ltr.pdf 6/18/2013
AP09/28/2013SCM       
AP011/14/2014SCM41045024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf 11/20/2014
AP011/14/2014SCM41122024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf 12/1/2014
AP01/16/2014SCM       
AP011/14/2014SLR41046026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/021038s019s024s026lbl.pdf 11/20/2014
AP011/14/2014SLR41123026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/021038Orig1s019,s024,s026ltr.pdf 12/1/2014
AP04/11/2016SLR45658027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/021038Orig1s027ltr.pdf 4/12/2016
AP04/11/2016SLR45663027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/021038s027lbl.pdf 4/12/2016




Back to FDA Applications sponsored by HOSPIRA