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FDA Drug Application 021716 by AKORN INC

Application Number021716
Application Type New Drug Application
Sponsor ApplicantAKORN INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP010/25/2005N12992000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/021716lbl.pdf 11/1/2005
AP010/25/2005N13012000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021716ltr.pdf 11/1/2005
AP010/25/2005N13311000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2005/021716s000_HydaseTOC.cfm 12/28/2005
AP011/5/2015SLR44423003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021716Orig1s003ltr.pdf 11/9/2015
AP011/5/2015SLR44442003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021716s003lbl.pdf 11/12/2015




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