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Back to FDA Applications sponsored by DR REDDYS LABS INC
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
Duplicate Counter
Action Date
Document Type
Application Document ID
Sequence Number
Document Title
Document URL
Document Date
AP
0
7/22/1985
N
AP
0
9/27/1985
SLR
AP
0
11/26/1985
SLR
AP
0
12/21/1985
SLR
AP
0
9/21/1986
SLR
AP
0
7/30/1987
SLR
AP
0
10/23/1987
SCM
AP
0
11/27/1987
SCF
AP
0
10/4/1989
SCS
AP
0
5/5/1988
SLR
AP
0
9/20/1988
SCS
AP
0
10/25/1991
SCS
AP
0
7/2/1989
SE2
AP
0
3/9/1989
SLR
AP
0
5/22/1991
SCS
AP
0
12/5/1991
SLR
AP
0
9/16/1992
SCS
AP
0
11/22/1991
SCS
AP
0
5/4/1992
SCS
AP
0
7/21/1992
SLR
AP
0
2/16/1996
SLR
AP
0
9/15/1994
SCS
AP
0
6/21/1994
SCP
AP
0
7/6/1994
SLR
AP
0
3/4/1996
SLR
AP
0
3/19/1997
SLR
AP
0
2/11/1998
SLR
AP
0
2/19/1998
SCM
AP
0
4/10/2002
SLR
8765
030
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/50564s34ltr.pdf
5/27/2004
AP
0
2/1/1999
SCS
AP
0
9/23/1999
SCS
AP
0
11/19/1999
SCS
AP
0
3/29/2001
SCS
AP
0
4/17/2001
SCS
AP
0
3/28/2002
SCS
AP
0
5/12/2003
SLR
5853
039
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50575slr032,50597slr039,50725slr017,50726slr014ltr.pdf
6/8/2003
AP
0
12/4/2002
SCS
AP
0
10/17/2002
SCS
AP
0
6/3/2004
SLR
9078
042
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575slr035,50597slr042,50725slr023,50726slr017ltr.pdf
6/7/2004
AP
0
8/11/2004
SLR
10000
043
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50575s036,50597s043,50725s024,50726s018ltr.pdf
8/12/2004
AP
0
12/4/2008
SLR
21329
044
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050575s037550597s044050725s025050726s019lbl.pdf
12/8/2008
AP
0
12/4/2008
SLR
21344
044
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050575s037, 050597s044, 050725025, 050726s019ltr.pdf
12/11/2008
AP
0
3/27/2008
SLR
19534
045
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050597s45,050575s38,050726s20,050725s26lbl.pdf
3/27/2008
AP
0
3/27/2008
SLR
19570
045
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050597s045, 050575s038, 050726s020, 050725s026ltr.pdf
4/2/2008
AP
0
9/29/2011
SLR
30212
046
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050575s039,050597s046,050725s027,050726s021ltr.pdf
10/4/2011
AP
0
9/29/2011
SLR
30344
046
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050597s046lbl.pdf
10/18/2011
AP
0
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
0
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
0
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
0
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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