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FDA Drug Application 017381 by KING PHARMS

Application Number017381
Application Type New Drug Application
Sponsor ApplicantKING PHARMS
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/26/1973N       
AP011/11/1974SLR       
AP07/17/1975SCS       
AP01/24/1977SCS       
AP05/24/1977SCM       
AP05/2/1977SCP       
AP04/6/1977SCS       
AP01/31/1978SCS       
AP09/28/1978SCS       
AP07/24/1978SLR       
AP04/17/1979SCS       
AP07/6/1979SCM       
AP06/14/1979SLR       
AP011/26/1979SCS       
AP06/26/1980SCS       
AP08/28/1981SCM       
AP03/4/1981SCS       
AP04/19/1982SCS       
AP09/15/1982SCE       
AP04/19/1982SCP       
AP09/10/1982SCP       
AP012/6/1982SCF       
AP012/6/1982SCM       
AP05/31/1984SCE       
AP06/12/1984SCF       
AP011/15/1985SCF       
AP011/28/1986SLR       
AP010/29/1987SCS       
AP011/14/1988SLR       
AP010/5/1992SLR       
AP01/29/1991SCM       
AP05/13/1991SCS       
AP02/27/1992SCS       
AP012/7/1992SCS       
AP011/4/1993SCM       
AP09/27/2001SCM       
AP01/29/2004SLR7674041   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/17381slr041ltr.pdf 2/3/2004
AP011/13/2012SCM       
AP03/6/2013SLR35353050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/017381Orig1s050ltr.pdf 3/6/2013
AP03/6/2013SLR35388050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/017381s050lbl.pdf 3/8/2013
AP04/30/2015SCM       
AP08/1/2016SCM46744053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/017381s053lbl.pdf 8/9/2016




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