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FDA Drug Application 021127 by MEDA PHARMS

Application Number021127
Application Type New Drug Application
Sponsor ApplicantMEDA PHARMS
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
AP05/22/2000N1269000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2000/21127ltr.pdf 5/22/2000
AP05/22/2000N1270000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2000/21127lbl.pdf 5/22/2000
AP05/22/2000N3066000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/21127_Optivar.cfm 5/22/2002
AP05/4/2001SCS       
AP04/4/2001SCE       
AP09/3/2004SLR10124003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127s003ltr.pdf 9/3/2004
AP04/30/2004SLR8513007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127slr007,008ltr.pdf 5/4/2004
AP04/30/2004SLR8508007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf 5/4/2004
AP04/30/2004SLR8509008   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21127slr007,008_optivar_lbl.pdf 5/4/2004
AP04/30/2004SLR8514008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21127slr007,008ltr.pdf 5/4/2004
AP07/3/2008SCP20160013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021127s013ltr.pdf 7/8/2008
AP07/3/2008SCP20175013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021127s013lbl.pdf 7/9/2008




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