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FDA Drug Application 020785 by CELGENE

Application Number020785
Application Type New Drug Application
Sponsor ApplicantCELGENE
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
AP07/16/1998N247000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20785ltr.pdf 7/16/1998
AP07/16/1998N248000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20785lbl.pdf 7/16/1998
AP07/16/1998N7212000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107296.htm 12/12/2003
AP07/16/1998N14789000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/98/020785s000_ThalidomideTOC.cfm 9/6/2006
AP07/16/1998N26217000   http://www.fda.gov/downloads/Drugs/DrugSafety/UCM222363.pdf 8/16/2010
AP07/16/1998N26227000REMS  http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm?event=IndvRemsDetails.page&REMS=58 8/16/2010
AP02/12/1999SCM       
AP05/28/1999SCS       
AP05/28/1999SCS       
AP010/28/1999SCP       
AP010/28/1999SCM       
AP010/28/1999SCS       
AP010/28/1999SCM       
AP05/15/2000SCM       
AP04/3/2000SCM       
AP09/4/2001SLR3961012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf 9/5/2001
AP09/4/2001SLR3962012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf 9/5/2001
AP09/4/2001SLR3963014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf 9/5/2001
AP09/4/2001SLR3964014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/20785s12s14ltr.pdf 9/5/2001
AP09/4/2001SLR5443014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/20785s12s14lbl.pdf 4/23/2003
AP011/1/2001SCM       
AP011/16/2001SCM       
AP011/16/2001SCS       
AP01/17/2003SCF4130020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf 1/17/2003
AP01/17/2003SCF4131020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf 1/17/2003
AP01/17/2003SCF17411020   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S020_THALOMID.pdf 7/27/2007
AP01/17/2003SLR17410021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2003/020785_S021_THALOMID.pdf 7/27/2007
AP01/17/2003SLR9470021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785scf020,021ltr.pdf 6/18/2004
AP01/17/2003SLR4206021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785scf020_Thalomid_lbl.pdf 3/6/2003
AP010/27/2003SLR6854022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf 10/31/2003
AP010/27/2003SLR6859022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf 10/31/2003
AP010/27/2003SLR6860023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf 10/31/2003
AP010/27/2003SLR6855023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf 10/31/2003
AP010/27/2003SLR6856024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20785slr022,023,024ltr.pdf 10/31/2003
AP010/27/2003SLR6861024   http://www.accessdata.fda.gov/drugsatfda_docs/label/2003/20785slr022,023,024_thalomid_lbl.pdf 10/31/2003
AP03/5/2004SLR7853025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf 3/10/2004
AP03/5/2004SLR7852026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20785slr025,026ltr.pdf 3/10/2004
AP05/25/2006SLR14177031   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/021430s000,020785s031lbl.pdf 5/26/2006
AP05/25/2006SLR14185031   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021430s000, 020785s031LTR.pdf 5/26/2006
AP01/10/2007SCS15667032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/020785s032_ltr.pdf 1/16/2007
AP02/3/2012SLR31715035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf 2/8/2012
AP02/3/2012SLR31669035   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf 2/6/2012
AP08/3/2010SLR26117039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020785s039ltr.pdf 8/6/2010
AP02/3/2012SE831716040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf 2/8/2012
AP02/3/2012SE831670040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf 2/6/2012
AP02/3/2012SLR31671043   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020785s035s040s043lbl.pdf 2/6/2012
AP02/3/2012SLR31717043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020785s035,s040,s043ltr.pdf 2/8/2012
AP02/8/2013SE835136048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s048ltr.pdf 2/12/2013
AP02/8/2013SE835145048   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/020785s048lbl.pdf 2/12/2013
AP011/15/2013S37840050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/020785Orig1s050ltr.pdf 11/18/2013
AP08/5/2015SLR43592051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020785s051lbl.pdf 8/7/2015
AP08/5/2015SLR43603051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s051ltr.pdf 8/10/2015
AP09/12/2014S40487054   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s054ltr.pdf 9/16/2014
AP06/19/2014SLR39611055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020785Orig1s055ltr.pdf 6/23/2014
AP06/19/2014SLR39627055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020785s055lbl.pdf 6/23/2014
AP09/13/2015SE843874057   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s057ltr.pdf 9/15/2015
AP010/27/2015SE844326058   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s058ltr.pdf 10/29/2015
AP012/1/2015SE844648059   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020785Orig1s059ltr.pdf 12/2/2015
AP04/22/2016S45740060   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/020785Orig1s060ltr.pdf 4/25/2016




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