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FDA Drug Application 050564 by DR REDDYS LABS INC

Application Number050564
Application Type New Drug Application
Sponsor ApplicantDR REDDYS LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type Approval
Chemical Type New molecular entity (NME); New combination
Therapeutic Potential Priority
Orphan Code 


  
Action TypeDuplicate CounterAction DateDocument TypeApplication Document IDSequence NumberDocument TitleDocument URLDocument Date
AP08/6/1984N       
AP011/21/1986SLR       
AP011/25/1985SLR       
AP012/21/1985SLR       
AP010/29/1987SLR       
AP011/27/1987SCF       
AP02/10/1988SCM       
AP05/5/1988SLR       
AP011/29/1988SCP       
AP02/7/1989SCP       
AP03/9/1989SLR       
AP05/22/1990SCM       
AP012/14/1991SLR       
AP09/16/1992SCS       
AP011/22/1991SCS       
AP06/22/1992SCS       
AP05/21/1992SCP       
AP07/21/1992SLR       
AP02/16/1996SLR3720022   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050564s022_augmentin.pdf 8/2/1999
AP09/15/1994SCS       
AP06/21/1994SCP       
AP07/6/1994SLR       
AP03/4/1996SLR       
AP03/19/1997SLR       
AP02/11/1998SLR       
AP02/12/1998SCM       
AP04/10/2002SLR8763034   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf 5/27/2004
AP02/1/1999SCS       
AP09/23/1999SCS       
AP011/19/1999SCS       
AP05/3/2001SCM       
AP04/17/2001SCS       
AP05/1/2002SCE       
AP07/25/2003SLR6510043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50564slr043,50720slr015ltr.pdf 8/15/2003
AP012/4/2002SCS       
AP010/17/2002SCS       
AP05/27/2004SLR8820046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564slr046,50720slr018ltr.pdf 6/1/2004
AP08/30/2004SLR10118047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50564s047,50720s019ltr.pdf 9/3/2004
AP08/5/2005SLR12587048   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2005/050564s048,050721s021ltr.pdf 8/11/2005
AP06/9/2008SLR19985049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s049,050720s022lbl.pdf 6/12/2008
AP06/9/2008SLR20001049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s049, 050720s022ltr.pdf 6/13/2008
AP012/4/2008SLR21332050   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s050lbl.pdf 12/8/2008
AP012/4/2008SLR21341050   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s050, 050720s023ltr.pdf 12/11/2008
AP03/26/2008SLR19539051   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050564s051lbl.pdf 3/27/2008
AP03/26/2008SLR19567051   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050564s051ltr.pdf 4/2/2008
AP09/29/2011SLR30170052   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050564s052,050720s025lbl.pdf 9/30/2011
AP09/29/2011SLR30206052   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050564s052,050720s025ltr.pdf 10/3/2011
AP01/22/2013SLR34942053   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34954053   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34955055   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34943055   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP09/30/2014SCM       




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