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FDA Drug Application 022180 by AMAG PHARMS INC

Application Number022180
Application Type New Drug Application
Sponsor ApplicantAMAG PHARMS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New ester, new salt, or other noncovalent derivative
Therapeutic Potential Standard
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP06/30/2009N22863000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2009/022180lbl.pdf 7/2/2009
AP06/30/2009N22886000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/022180s000ltr.pdf 7/7/2009
AP06/30/2009N24153000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000TOC.cfm 11/25/2009
AP06/30/2009N24154000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2009/022180s000_SumR.pdf 11/25/2009
AP011/24/2010SLR27097003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf 11/30/2010
AP011/24/2010SLR27115003   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf 12/1/2010
AP011/24/2010SLR27098005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/022180s003,022180s005ltr.pdf 11/30/2010
AP011/24/2010SLR27116005   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/022180s003s005lbl.pdf 12/1/2010
AP06/21/2011SLR29298006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/022180s006ltr.pdf 6/28/2011
AP06/21/2011SLR29321006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/022180s006lbl.pdf 6/29/2011
AP012/23/2013SCM38173010   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/022180s010lbl.pdf 12/24/2013
AP03/16/2015SLR42166011   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf 3/17/2015
AP03/16/2015SLR42199011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf 3/19/2015
AP07/27/2015SCM       
AP03/16/2015SLR42165013   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/022180Orig1s011,022180Orig1s013ltr_corrected.pdf 3/17/2015
AP03/16/2015SLR42200013   http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/022180s011s013lbl.pdf 3/19/2015
AP010/28/2015SCM       
AP010/26/2015SCM       




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