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FDA Drug Application 021574 by ANDRX LABS LLC

Application Number021574
Application Type New Drug Application
Sponsor ApplicantANDRX LABS LLC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New manufacturer
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP04/28/2004N8409000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/21574ltr.pdf 4/29/2004
AP04/28/2004N8505000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2004/21574_fortamet_lbl.pdf 5/4/2004
AP04/28/2004N13593000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2004/021574s000_ForametTOC.cfm 2/8/2006
AP02/8/2006SLR13656005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/021574s005ltr.pdf 2/22/2006
AP04/19/2007SLR16259006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2007/021574s006lbl.pdf 4/20/2007
AP04/19/2007SLR16306006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2007/021574s006)_LTR.pdf 4/25/2007
AP07/29/2008SLR20342010   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/021574s010ltr.pdf 7/31/2008
AP07/29/2008SLR20603010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021574s010lbl.pdf 8/13/2008
AP05/18/2015SCM       
AP08/24/2016SCM       




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