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FDA Drug Application 018651 by ABBVIE

Application Number018651
Application Type New Drug Application
Sponsor ApplicantABBVIE
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP05/31/1985N       
AP01/28/1986SLR       
AP03/31/1989SCS       
AP03/31/1993SCS       
AP03/3/1992SCM       
AP012/22/1992SE1       
AP03/5/2002SCM       
AP010/30/2001SCM       
AP08/5/1999SLR1344011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/18651S011_Marinol.pdf 8/5/1999
AP06/21/2000SCM       
AP09/22/2000SLR46756013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/018651s013lbl.pdf 8/10/2016
AP04/5/2001SCM       
AP01/17/2002SCM       
AP09/6/2002SCS       
AP09/6/2002SCS       
AP04/28/2003SLR5575018   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/018651s018lbl.pdf 5/6/2003
AP04/28/2003SLR5735018   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/18651slr018ltr.pdf 5/29/2003
AP05/21/2004SCM       
AP04/26/2005SLR11533021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/018651s021ltr.pdf 4/28/2005
AP04/26/2005SLR11535021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/018651s021lbl.pdf 4/28/2005
AP06/21/2006SLR14372025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018651s025,s026LTR.pdf 6/28/2006
AP06/21/2006SLR14374025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf 6/28/2006
AP06/21/2006SLR14373026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/018651s025,s026LTR.pdf 6/28/2006
AP06/21/2006SLR14375026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/018651s025s026lbl.pdf 6/28/2006




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