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FDA Drug Application 050597 by DR REDDYS LABS INC

Application Number050597
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
AP07/22/1985N       
AP09/27/1985SLR       
AP011/26/1985SLR       
AP012/21/1985SLR       
AP09/21/1986SLR       
AP07/30/1987SLR       
AP010/23/1987SCM       
AP011/27/1987SCF       
AP010/4/1989SCS       
AP05/5/1988SLR       
AP09/20/1988SCS       
AP010/25/1991SCS       
AP07/2/1989SE2       
AP03/9/1989SLR       
AP05/22/1991SCS       
AP012/5/1991SLR       
AP09/16/1992SCS       
AP011/22/1991SCS       
AP05/4/1992SCS       
AP07/21/1992SLR       
AP02/16/1996SLR       
AP09/15/1994SCS       
AP06/21/1994SCP       
AP07/6/1994SLR       
AP03/4/1996SLR       
AP03/19/1997SLR       
AP02/11/1998SLR       
AP02/19/1998SCM       
AP04/10/2002SLR8765030   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf 5/27/2004
AP02/1/1999SCS       
AP09/23/1999SCS       
AP011/19/1999SCS       
AP03/29/2001SCS       
AP04/17/2001SCS       
AP03/28/2002SCS       
AP05/12/2003SLR5853039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf 6/8/2003
AP012/4/2002SCS       
AP010/17/2002SCS       
AP06/3/2004SLR9078042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf 6/7/2004
AP08/11/2004SLR10000043   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf 8/12/2004
AP012/4/2008SLR21329044   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf 12/8/2008
AP012/4/2008SLR21344044   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf 12/11/2008
AP03/27/2008SLR19534045   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf 3/27/2008
AP03/27/2008SLR19570045   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf 4/2/2008
AP09/29/2011SLR30212046   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf 10/4/2011
AP09/29/2011SLR30344046   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf 10/18/2011
AP01/22/2013SLR34946047   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34958047   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34959049   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34947049   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013




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