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FDA Drug Application 019676 by GENENTECH

Application Number019676
Application Type New Drug Application
Sponsor ApplicantGENENTECH
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan CodeV


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP03/9/1994N       
AP07/21/1994SCM       
AP08/3/1994SCM       
AP02/3/1995SCM       
AP02/1/1996SCM       
AP09/22/1995SCS       
AP08/21/1995SLR       
AP08/7/1996SCS       
AP012/15/1997SE1       
AP09/12/1997SCS       
AP09/25/1998SCS       
AP09/25/1998SCS       
AP012/1/1999SE85515013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin.cfm 4/29/2003
AP012/1/1999SE89286013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/19676S13_nutropin_approv.pdf 6/10/2004
AP011/3/1999SCM       
AP011/24/1999SLR       
AP04/13/2000SE21332016   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/19676S16LTR.PDF 4/13/2000
AP04/13/2000SE26103016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676s016_Nutropin.cfm 7/8/2003
AP04/13/2000SE29285016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/19-676S016_Nutropin_prntlbl.pdf 6/10/2004
AP05/2/2001SCM       
AP09/17/2001SCM       
AP06/28/2005SE111907020   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf 6/29/2005
AP06/28/2005SE111927020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf 6/29/2005
AP06/28/2005SE112215020Additional App Ltr  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf 7/22/2005
AP06/28/2005SE112278020Additional Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf 7/26/2005
AP06/28/2005SLR11908021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021_rel2_ltr.pdf 6/29/2005
AP06/28/2005SLR11928021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021lbl.pdf 6/29/2005
AP06/28/2005SLR12216021Additional App Ltr  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf 7/22/2005
AP06/28/2005SLR12279021Additional Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/019676s020,021_rel2_lbl.pdf 7/26/2005
AP02/23/2006SE813664026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/019676s026lbl.pdf 2/28/2006
AP02/23/2006SE813687026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/019676s026ltr.pdf 3/1/2006
AP02/15/2007SLR15856030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf 2/21/2007
AP02/15/2007SLR15887030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf 2/23/2007
AP04/10/2012SLR32408042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf 4/12/2012
AP04/10/2012SLR32448042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/019676s042lbl.pdf 4/17/2012




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