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FDA Drug Application 020323 by NOVARTIS

Application Number020323
Application Type New Drug Application
Sponsor ApplicantNOVARTIS
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
AP010/28/1994N       
AP03/21/1995SCS       
AP06/9/1995SCS       
AP010/2/1995SLR       
AP06/20/1995SCM       
AP08/9/1995SCS       
AP04/10/1996SCM       
AP012/11/1995SLR       
AP012/7/1995SLR       
AP02/21/1996SCS       
AP02/21/1996SCM       
AP01/9/1997SCS       
AP07/10/1996SCS       
AP05/29/1997SLR       
AP07/22/1997SCS       
AP07/23/1997SCS       
AP01/22/2004SLR7647017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf 2/2/2004
AP01/22/2004SLR7655017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf 2/3/2004
AP010/28/1998SCM       
AP010/27/1998SCM       
AP04/1/1999SCS       
AP02/25/2000SE82821021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S21LTR.PDF 2/29/2000
AP02/25/2000SE82822021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S21LBL.PDF 2/28/2000
AP02/25/2000SE88090021   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/20-323S021_Vivelle.cfm 3/28/2004
AP010/29/1999SCS       
AP08/16/2000SLR8330023   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21-167_20-323S23_Vivelle.cfm 4/13/2004
AP08/16/2000SLR2819023   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/20323S23ltr.pdf 8/16/2000
AP08/16/2000SLR2820023   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/20323S23lbl.pdf 8/16/2000
AP02/1/2001SCS       
AP01/22/2004SLR7656025   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf 2/3/2004
AP01/22/2004SLR7648025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf 2/2/2004
AP07/3/2001SCM       
AP010/31/2001SCS       
AP03/28/2002SCS       
AP07/18/2002SCS       
AP01/22/2004SLR7649030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323slr017,025,030ltr.pdf 2/2/2004
AP01/22/2004SLR7657030   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323slr017,025,030_vivelle_lbl.pdf 2/3/2004
AP08/6/2004SLR9981033   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20323s033ltr.pdf 8/10/2004
AP08/6/2004SLR9984033   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20323s033lbl.pdf 8/10/2004




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