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FDA Drug Application 050597 by DR REDDYS LABS INC

Application Number	050597
Application Type	New Drug Application
Sponsor Applicant	DR REDDYS LABS INC
Most Recent Label Available Flag
Current Patent Flag
Action Type	Approval
Chemical Type	New formulation
Therapeutic Potential	Standard
Orphan Code

Action Type	Action Date	Document Type	Application Document ID	Sequence Number	Document URL	Document Date
AP	7/22/1985	N
AP	9/27/1985	SLR
AP	11/26/1985	SLR
AP	12/21/1985	SLR
AP	9/21/1986	SLR
AP	7/30/1987	SLR
AP	10/23/1987	SCM
AP	11/27/1987	SCF
AP	10/4/1989	SCS
AP	5/5/1988	SLR
AP	9/20/1988	SCS
AP	10/25/1991	SCS
AP	7/2/1989	SE2
AP	3/9/1989	SLR
AP	5/22/1991	SCS
AP	12/5/1991	SLR
AP	9/16/1992	SCS
AP	11/22/1991	SCS
AP	5/4/1992	SCS
AP	7/21/1992	SLR
AP	2/16/1996	SLR
AP	9/15/1994	SCS
AP	6/21/1994	SCP
AP	7/6/1994	SLR
AP	3/4/1996	SLR
AP	3/19/1997	SLR
AP	2/11/1998	SLR
AP	2/19/1998	SCM
AP	4/10/2002	SLR	8765	030	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf	5/27/2004
AP	2/1/1999	SCS
AP	9/23/1999	SCS
AP	11/19/1999	SCS
AP	3/29/2001	SCS
AP	4/17/2001	SCS
AP	3/28/2002	SCS
AP	5/12/2003	SLR	5853	039	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf	6/8/2003
AP	12/4/2002	SCS
AP	10/17/2002	SCS
AP	6/3/2004	SLR	9078	042	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf	6/7/2004
AP	8/11/2004	SLR	10000	043	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf	8/12/2004
AP	12/4/2008	SLR	21329	044	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf	12/8/2008
AP	12/4/2008	SLR	21344	044	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf	12/11/2008
AP	3/27/2008	SLR	19534	045	http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf	3/27/2008
AP	3/27/2008	SLR	19570	045	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf	4/2/2008
AP	9/29/2011	SLR	30212	046	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf	10/4/2011
AP	9/29/2011	SLR	30344	046	http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf	10/18/2011
AP	1/22/2013	SLR	34946	047	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf	1/23/2013
AP	1/22/2013	SLR	34958	047	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf	1/24/2013
AP	1/22/2013	SLR	34947	049	http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/050564s053s055,050575s040s042,050597s047s049,050720s026s028,050725s028s030,050726s022s024lbl.pdf	1/23/2013
AP	1/22/2013	SLR	34959	049	http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/050564Orig1s053s055,050575s040s042,050597s04s049,050720s026s028,050720s026s028,050725s028s030,050726s022ltr.pdf	1/24/2013

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