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FDA Drug Application 021200 by US WORLDMEDS LLC

Application Number021200
Application Type New Drug Application
Sponsor ApplicantUS WORLDMEDS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME)
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP07/24/2002N21802000   http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103223.htm 12/12/2003
AP07/24/2002N21803000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21200ltr.pdf 7/24/2002
AP07/24/2002N21804000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/21200lbl.pdf 7/24/2002
AP07/24/2002N21805000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/21-200_Zelnorm.cfm 7/22/2002
AP08/21/2004SE110041005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200s005ltr.pdf 8/25/2004
AP08/21/2004SE110078005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200s005lbl.pdf 8/25/2004
AP06/15/2004SCM9403006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scm006ltr.pdf 6/16/2004
AP06/15/2004SCM9410006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scm006_zelnorm_lbl.pdf 6/16/2004
AP04/21/2004SCP8418007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf 4/29/2004
AP04/21/2004SCP8494007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf 5/4/2004
AP04/21/2004SCF8419008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21200scp007,scf008ltr.pdf 4/29/2004
AP04/21/2004SCF8495008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21200scp007,scf008_zelnorm_lbl.pdf 5/4/2004
AP04/15/2004SLR8400009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/021200s009ltr.pdf 4/27/2004
AP04/15/2004SLR8401009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021200s009lbl.pdf 4/27/2004
AP05/25/2005SCM11716010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/021200s010ltr.pdf 5/26/2005
AP06/2/2006SCM14237012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021200s012LTR.pdf 6/6/2006
AP03/1/2007SLR15949014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021200s014ltr.pdf 3/6/2007
AP03/1/2007SLR15993014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021200s014lbl.pdf 3/7/2007




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