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FDA Drug Application 012015 by OAK PHARMS AKORN

Application Number012015
Application Type New Drug Application
Sponsor ApplicantOAK PHARMS AKORN
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
AP012/21/1959N       
AP07/1/1974SOA       
AP01/15/1975SLR       
AP05/5/1977SLR       
AP04/19/1979SLR       
AP05/14/1981SCS       
AP010/19/1981SCM       
AP011/2/1981SCP       
AP01/14/1986SLR       
AP010/31/1988SCM       
AP09/26/1996SLR       
AP04/15/1996SCM       
AP05/22/2001SLR2530023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/12015s23ltr.pdf 5/22/2001
AP07/24/1998SCS       
AP07/27/1998SCS       
AP04/22/2013SLR35774026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s026lbl.pdf 4/22/2013
AP04/22/2013SLR35838026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf 4/24/2013
AP04/22/2013SLR35776027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/012015s027lbl.pdf 4/22/2013
AP04/22/2013SLR35839027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/12015Orig1s026,s027ltr.pdf 4/24/2013
AP06/26/2013SCM       
AP02/3/2015SCM       




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