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FDA Drug Application 200403 by HOSPIRA INC

Application Number200403
Application Type New Drug Application
Sponsor ApplicantHOSPIRA INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type Drug already marketed, but without an approved NDA
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
TA02/25/2011TA28021000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000TAltr.pdf 3/2/2011
TA02/25/2011TA30864000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200403s000lbl.pdf 12/2/2011
TA02/25/2011TA30881000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000ltr.pdf 12/5/2011
TA02/25/2011TA32801000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403_hydromorphone_toc.cfm 6/5/2012
TA02/25/2011TA32802000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403Orig1s000SumR.pdf 6/5/2012
AP112/1/2011N28021000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000TAltr.pdf 3/2/2011
AP112/1/2011N30864000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/200403s000lbl.pdf 12/2/2011
AP112/1/2011N30881000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/200403s000ltr.pdf 12/5/2011
AP112/1/2011N32801000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403_hydromorphone_toc.cfm 6/5/2012
AP112/1/2011N32802000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2011/200403Orig1s000SumR.pdf 6/5/2012
AP06/11/2013SCM       
AP08/18/2014SCM       
AP07/16/2015SLR43403004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/200403s004lbl.pdf 7/17/2015
AP07/16/2015SLR43414004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/200403Orig1s004ltr.pdf 7/20/2015
AP09/3/2015SCM       




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