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FDA Drug Application 021443 by TEVA WOMENS

Application Number021443
Application Type New Drug Application
Sponsor ApplicantTEVA WOMENS
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
AP05/10/2004N8568000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/021443lbl.pdf 5/19/2004
AP05/10/2004N8638000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21443ltr.pdf 5/26/2004
AP05/10/2004N14536000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021443s000_EnjuviaTOC.cfm 7/27/2006
AP04/23/2007SE116291004   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021443s004lbl.pdf 4/25/2007
AP04/23/2007SE116416004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s004ltr.pdf 5/1/2007
AP04/27/2007SCS16376005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021443s005ltr.pdf 5/1/2007
AP06/30/2015SLR43174009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/021443s009lbl.pdf 7/1/2015
AP06/30/2015SLR43280009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/021443Orig1s009ltr.pdf 7/9/2015




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