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FDA Drug Application 021308 by MEDTECH PRODUCTS

Application Number021308
Application Type New Drug Application
Sponsor ApplicantMEDTECH PRODUCTS
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
AP06/29/2001N5589000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2001/21308lbl.pdf 5/7/2003
AP06/29/2001N9236000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2001/21308ltr.pdf 6/9/2004
AP06/29/2001N9237000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2001/21-308_Monistat.cfm 6/9/2004
AP05/6/2002SCM       
AP04/10/2002SCP       
AP010/28/2002SCS       
AP09/6/2002SCP9234004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308scp004ltr.pdf 6/9/2004
AP011/20/2002SLR9235005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/21308slr005ltr.pdf 6/9/2004
AP012/3/2003SCP7060008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/21308scp008ltr.pdf 12/8/2003
AP010/1/2004SE210366009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21308s009ltr.pdf 10/5/2004
AP010/1/2004SE210369009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21308s009lbl.pdf 10/5/2004
AP010/1/2004SE218501009   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021308_S009_MONISTAT 1.pdf 11/19/2007
AP04/4/2005SLR11345010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/21308s010ltr.pdf 4/6/2005
AP02/6/2013SCM       
AP07/10/2013SCM       
AP03/13/2013SCM35462020   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021308s020lbl.pdf 3/15/2013
AP02/11/2014SCM       




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