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FDA Drug Application 020687 by DANCO LABS LLC

Application Number020687
Application Type New Drug Application
Sponsor ApplicantDANCO LABS LLC
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
AP09/28/2000N128000 9/28/2000
AP09/28/2000N129000 9/28/2000
AP09/28/2000N130000 9/28/2000
AP09/28/2000N15085000 10/12/2006
AP09/28/2000N24016000 11/19/2009
AP011/15/2004SLR10582010 11/15/2004
AP011/15/2004SLR10583010 11/15/2004
AP012/22/2004SLR10819011 12/29/2004
AP07/19/2005SLR12024013 7/19/2005
AP07/19/2005SLR12028013 7/21/2005
AP06/8/2011SLR29070014 6/9/2011
AP06/8/2011SLR29106014 6/10/2011
AP06/8/2011SLR45556014REMS approved 6/8/2011 3/30/2016
AP04/27/2009SLR28558015 4/18/2011
AP04/27/2009SLR22330015 4/28/2009
AP04/27/2009SLR22431015 5/6/2009
AP03/29/2016SE245557020REMS 3/30/2016
AP03/29/2016SE245558020 3/30/2016
AP03/29/2016SE245540020 3/30/2016
AP03/29/2016SE245541020 3/30/2016

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