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FDA Drug Application 050785 by DR REDDYS LABS INC

Application Number050785
Application Type New Drug Application
Sponsor ApplicantDR REDDYS LABS INC
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
AP09/25/2002N6022000   http://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/50785_AugmentinXR.cfm 7/6/2003
AP09/25/2002N4572000   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50785ltr.pdf 9/25/2002
AP09/25/2002N4573000   http://www.accessdata.fda.gov/drugsatfda_docs/label/2002/50785lbl.pdf 9/25/2002
AP05/20/2003SLR5859002   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785slr002ltr.pdf 6/8/2003
AP05/30/2003SCS5858003   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50785scs003ltr.pdf 6/8/2003
AP05/24/2004SLR8627004   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785slr004ltr.pdf 5/26/2004
AP09/16/2004SLR10230005   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50785s005ltr.pdf 9/17/2004
AP06/15/2005SE811836006   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050785s006ltr.pdf 6/21/2005
AP06/15/2005SE811854006   http://www.accessdata.fda.gov/drugsatfda_docs/label/2005/050785s006lbl.pdf 6/21/2005
AP012/10/2008SLR21375007   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s007ltr.pdf 12/19/2008
AP012/10/2008SLR21488007   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050785s007lbl.pdf 1/2/2009
AP04/17/2008SLR19699008   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050785s008ltr.pdf 4/22/2008
AP08/26/2011SLR29925009   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050785s009lbl.pdf 8/30/2011
AP08/26/2011SLR29932009   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050755s016,s018,050785s009ltr.pdf 8/31/2011
AP08/27/2010SLR26470011   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf 9/10/2010
AP08/27/2010SLR26471012   http://www.accessdata.fda.gov/drugsatfda_docs/label/2010/050785s011s012lbl.pdf 9/10/2010
AP08/27/2010SLR26432012   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2010/050785s011,s012ltr.pdf 9/9/2010
AP011/27/2013SLR37956014   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050785Orig1s014ltr.pdf 11/29/2013
AP011/27/2013SLR37958014   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050785s014lbl.pdf 12/3/2013
AP04/4/2014SLR38985015   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2014/050785s015ltr.pdf 4/7/2014
AP04/4/2014SLR38999015   http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/050785s015lbl.pdf 4/8/2014
AP09/30/2014SCM       




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