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FDA Drug Application 020522 by GENENTECH

Application Number020522
Application Type New Drug Application
Sponsor ApplicantGENENTECH
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
AP012/29/1995N       
AP08/7/1996SCS       
AP03/24/1997SE14314002   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522_s002ap.pdf 3/24/1997
AP09/12/1997SCS       
AP012/17/1997SE14315004   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020522a_s004.pdf 12/17/1997
AP07/9/1998SCS       
AP010/26/1998SCM       
AP09/25/1998SCS       
AP09/25/1998SCS       
AP012/1/1999SE83053009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/20522S9LTR.PDF 12/1/1999
AP012/1/1999SE85635009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20522S9.PDF 5/15/2003
AP011/3/1999SCM       
AP011/24/1999SLR17512011   http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/020522_S011_NUTROPIN FOR INJ.pdf 8/6/2007
AP010/13/1999SCS       
AP04/13/2000SE26110013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522s013_Somatropin.cfm 7/8/2003
AP04/13/2000SE29284013   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-522S013_Somatropin_prntlbl.pdf 6/10/2004
AP04/13/2000SE21356013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20522S13LTR.PDF 4/13/2000
AP09/17/2001SCS       
AP05/2/2001SCM       
AP09/17/2001SCM       
AP04/22/2002SCP3051017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20522s017.pdf 4/22/2002
AP04/22/2002SCP3052017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/20522s17lbl.pdf 4/22/2002
AP06/28/2005SE111924021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf 6/29/2005
AP06/28/2005SE111910021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf 6/29/2005
AP06/28/2005SE112280021Additional Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf 7/26/2005
AP06/28/2005SE112217021Additional App Ltr  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf 7/22/2005
AP06/28/2005SLR12218022Additional App Ltr  http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/019676s020,021,020522s021,022_letter2.pdf 7/22/2005
AP06/28/2005SLR12281022Additional Label  http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022_rel2_lbl.pdf 7/26/2005
AP06/28/2005SLR11911022   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s021,022_rel2_ltr.pdf 6/29/2005
AP06/28/2005SLR11925022   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s021,022lbl.pdf 6/29/2005
AP01/3/2008SCM18737026   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf 1/8/2008
AP01/3/2008SCM18802026   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf 1/9/2008
AP011/18/2005SE813129027   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/020522s027lbl.pdf 11/22/2005
AP011/18/2005SE813130027   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/020522s027ltr.pdf 11/22/2005
AP02/15/2007SLR15857033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/019676s030,020522s033lbl.pdf 2/21/2007
AP02/15/2007SLR15886033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/019676s030, 020522s033ltr.pdf 2/23/2007
AP01/3/2008SCS18738036   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf 1/8/2008
AP01/3/2008SCS18803036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf 1/9/2008
AP01/3/2008SCS18804037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/020522s026,s036,s037ltr.pdf 1/9/2008
AP01/3/2008SCS18739037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/020522s026s036s037lbl.pdf 1/8/2008
AP04/10/2012SLR32409045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/019676s042,020522s045ltr.pdf 4/12/2012
AP04/10/2012SLR32450045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020522s045lbl.pdf 4/17/2012
AP07/18/2013SCM       
AP09/17/2013SCM       
AP06/16/2014SLR39555051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020522s051lbl.pdf 6/17/2014
AP06/16/2014SLR39580051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/020522Orig1s051ltr.pdf 6/18/2014
AP05/15/2014SCM       
AP05/26/2015SCM       
AP06/23/2015SCM       
AP01/13/2016SCM       
AP02/26/2016SCM       
AP03/17/2016SCM       
AP05/18/2016SCM       




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