Back to FDA Applications sponsored by DR REDDYS LABS INC

FDA Drug Application 050575 by DR REDDYS LABS INC

Application Number050575
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
AP08/6/1984N       
AP05/22/1991SCM       
AP012/5/1991SLR       
AP04/18/1994SCS       
AP011/5/1991SCS       
AP07/21/1992SLR       
AP02/16/1996SLR3721016   http://www.accessdata.fda.gov/drugsatfda_docs/nda/96/050564s022_augmentin.pdf 8/2/1999
AP09/15/1994SCS       
AP07/6/1994SLR       
AP03/4/1996SLR       
AP03/19/1997SLR       
AP02/11/1998SLR       
AP02/11/1998SCM       
AP04/10/2002SLR8764025   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf 5/27/2004
AP02/1/1999SCS       
AP09/23/1999SCS       
AP011/19/1999SCS       
AP04/17/2001SCS       
AP05/12/2003SLR5852032   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf 6/8/2003
AP012/4/2002SCS       
AP010/17/2002SCS       
AP06/3/2004SLR9077035   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf 6/7/2004
AP08/11/2004SLR9999036   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf 8/12/2004
AP012/4/2008SLR21328037   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf 12/8/2008
AP012/4/2008SLR21343037   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf 12/11/2008
AP03/27/2008SLR19535038   http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf 3/27/2008
AP03/27/2008SLR19571038   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf 4/2/2008
AP09/29/2011SLR30171039   http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050575s039,050597s046,050725s027,050726s021lbl.pdf 9/30/2011
AP09/29/2011SLR30211039   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf 10/4/2011
AP01/22/2013SLR34944040   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP01/22/2013SLR34956040   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34957042   http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf 1/24/2013
AP01/22/2013SLR34945042   http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf 1/23/2013
AP09/30/2014SCM       




Back to FDA Applications sponsored by DR REDDYS LABS INC

Problems, Comments, Suggestions? Click here to contact Greg Thatcher

Please read my Disclaimer





Copyright (c) 2013 Thatcher Development Software, LLC. All rights reserved. No claim to original U.S. Gov't works.