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FDA Drug Application 020992 by TEVA BRANDED PHARM

Application Number020992
Application Type New Drug Application
Sponsor ApplicantTEVA BRANDED PHARM
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New formulation
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/24/1999N829000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20992ltr.htm 3/24/1999
AP03/24/1999N830000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20992.cfm 3/24/1999
AP03/24/1999N831000   http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/20992lbl.pdf 3/24/1999
AP09/7/1999SCS       
AP011/2/1999SCP       
AP011/12/1999SCS       
AP011/8/1999SCS       
AP01/7/2000SCS       
AP03/13/2000SCF       
AP01/27/2000SCM       
AP08/9/2000SCS       
AP02/22/2002SLR2377011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s11ltr.pdf 2/22/2002
AP07/20/2001SCM       
AP09/5/2001SCS       
AP09/10/2001SCS       
AP09/5/2001SCS       
AP06/21/2002SE116800016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020992_S016_CENESTINTOC.cfm 6/18/2007
AP06/21/2002SE12375016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20992s016LTR.pdf 6/21/2002
AP06/21/2002SE12376016   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20992s16lbl.pdf 6/21/2002
AP02/8/2002SCS       
AP02/8/2002SCS       
AP03/5/2002SCS       
AP04/29/2002SCM       
AP02/5/2004SE27804021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992se2-021ltr.pdf 3/3/2004
AP02/5/2004SE28204021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992se2-021_cenestin_lbl.pdf 4/5/2004
AP010/18/2002SCM       
AP011/5/2002SCS       
AP01/28/2004SLR7638024   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992slr024ltr.pdf 2/2/2004
AP010/28/2004SLR10491026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20992s026ltr.pdf 10/29/2004
AP010/28/2004SLR10519026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20992s026lbl.pdf 11/1/2004
AP03/20/2015SLR42237034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/020992Orig1s034ltr.pdf 3/24/2015
AP03/20/2015SLR42253034   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/020992s034lbl.pdf 3/24/2015




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