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FDA Drug Application 016860 by NOVEN THERAP

Application Number016860
Application Type New Drug Application
Sponsor ApplicantNOVEN THERAP
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/6/1970N       
AP08/23/1974SSR       
AP06/17/1974SLR       
AP07/1/1975SLR       
AP08/29/1975SCS       
AP08/29/1975SCS       
AP08/29/1975SCS       
AP010/4/1977SLR       
AP01/25/1978SLR       
AP04/24/1979SLR       
AP09/27/1979SLR       
AP09/27/1979SLR       
AP02/6/1980SLR       
AP02/6/1980SLR       
AP04/16/1980SCF       
AP09/19/1980SLR       
AP09/11/1981SLR       
AP012/2/1981SLR       
AP04/29/1982SLR       
AP011/18/1982SCS       
AP01/27/1983SLR       
AP05/8/2002SLR3424059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf 5/8/2002
AP011/30/1984SCS       
AP05/8/2002SLR3425065   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf 5/8/2002
AP08/30/1994SCM       
AP05/8/2002SLR3426067   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf 5/8/2002
AP05/8/2002SLR3427068   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf 5/8/2002
AP05/8/2002SLR3428069   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf 5/8/2002
AP02/1/2000SCM       
AP04/6/2000SCM       
AP05/8/2002SLR3429072   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860s59s65s67s68s69s72ltr.pdf 5/8/2002
AP08/5/2002SLR8967073   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/16860slr073,17971slr019,18152slr017ltr.pdf 6/3/2004
AP03/11/2004SLR7947074   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/16860slr074,18152slr020ltr.pdf 3/16/2004
AP03/11/2004SLR8286074   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/16860slr074,18152slr020_eskalith_lbl.pdf 4/5/2004




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