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FDA Drug Application 020768 by IPR

Application Number020768
Application Type New Drug Application
Sponsor ApplicantIPR
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP011/25/1997N15676000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm101549.htm 1/17/2007
AP011/25/1997N24661000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/97/020768_toc.cfm 1/29/2010
AP07/21/1998SCM       
AP02/16/1999SCS       
AP05/1/2000SLR       
AP011/29/1999SCM       
AP02/14/2000SCM       
AP01/29/2002SLR2181006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768s6ltr.pdf 1/29/2002
AP03/9/2000SCM       
AP09/12/2000SCM       
AP012/18/2000SCM       
AP010/9/2002SLR2182010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/20768slr010,21231slr003ltr.pdf 10/9/2002
AP010/9/2002SLR19194010   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/020768_S010_ZOMIG_TABLETS.pdf 2/19/2008
AP05/21/2003SLR5827011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/20768slr011,21231slr004ltr.pdf 6/8/2003
AP011/16/2004SE510627012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/20768s012ltr.pdf 11/19/2004
AP011/16/2004SE510628012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/20768s012lbl.pdf 11/19/2004
AP01/8/2004SLR7529013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21231slr005,20768slr013ltr.pdf 1/14/2004
AP08/11/2010SLR26213017   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/020768s017ltr.pdf 8/16/2010
AP08/11/2010SLR26254017   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/020768s017lbl.pdf 8/19/2010
AP09/14/2012SLR33777019   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf 9/18/2012
AP09/14/2012SLR33789019   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf 9/18/2012
AP09/14/2012SLR33778021   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2012/020768Orig1s019,s021,021231Orig1s010,s011ltr.pdf 9/18/2012
AP09/14/2012SLR33790021   http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/020768s019s021,021231s010s011lbl.pdf 9/18/2012
AP03/12/2014SCM       




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