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Back to FDA Applications sponsored by DR REDDYS LABS INC
FDA Drug Application 050760 by DR REDDYS LABS INC
Application Number
050760
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
4/15/1999
N
4393
000
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/1999/50760ltr.pdf
4/15/1999
AP
0
4/15/1999
N
4394
000
http://www.accessdata.fda.gov/drugsatfda_docs/label/1999/50760lbl.pdf
4/15/1999
AP
0
4/15/1999
N
11973
000
http://www.accessdata.fda.gov/drugsatfda_docs/nda/99/050760_s000_AmoxilTOC.cfm
7/11/2005
AP
0
5/16/2000
SLR
10162
001
http://www.accessdata.fda.gov/drugsatfda_docs/nda/2000/50-542s017_50-754s002_50-760s001_50-761s001_Amoxil.cfm
9/9/2004
AP
0
4/17/2001
SCS
AP
0
5/12/2003
SLR
5847
003
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr019,50754slr004,50760slr003,50761slr003ltr.pdf
6/8/2003
AP
0
4/25/2002
SCS
AP
0
5/1/2002
SCE
AP
0
12/4/2002
SCS
AP
0
12/18/2003
SLR
7306
007
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2003/50542slr021,50760slr007,50754slr008,50761slr007ltr.pdf
12/22/2003
AP
0
7/13/2004
SLR
9759
008
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2004/50542s022,50754s009,50760s008,50761s008rltr.pdf
7/21/2004
AP
0
1/26/2006
SLR
13518
009
http://www.accessdata.fda.gov/drugsatfda_docs/label/2006/050761s009_050760s009lbl.pdf
1/27/2006
AP
0
1/26/2006
SLR
13563
009
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2006/050761s009_050760s009ltr.pdf
1/30/2006
AP
0
6/9/2008
SLR
19981
010
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050542s24,050754s11,050760s10,050761s10lbl.pdf
6/12/2008
AP
0
6/9/2008
SLR
20005
010
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050542s024, 050754s011, 050760s010, 050761s010ltr.pdf
6/13/2008
AP
0
3/28/2008
SLR
19559
011
http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/050760s11,050761s11,050754s12,050542s25lbl.pdf
4/1/2008
AP
0
3/28/2008
SLR
19575
011
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2008/050760s011, 050761s011,050754s012, 050542s025ltr.pdf
4/2/2008
AP
0
11/16/2011
SLR
30678
012
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf
11/21/2011
AP
0
11/16/2011
SLR
30709
012
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/21/2011
AP
0
11/16/2011
SLR
30679
013
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf
11/21/2011
AP
0
11/16/2011
SLR
30710
013
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/21/2011
AP
0
11/16/2011
SLR
30680
015
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2011/050542s026,s027,s028,050754s013,s014,s017,050760s012,s013,s015,050761s012,s013,s015ltr.pdf
11/21/2011
AP
0
11/16/2011
SLR
30708
015
http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050542s026s027s028,050754s013s014s017,050760s012s013s015,050761s012s013s015lbl.pdf
11/21/2011
AP
0
7/30/2014
SCM
AP
0
5/29/2014
SCM
AP
0
9/24/2015
SLR
44006
019
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Origs029,050754Orig1s019,050760Orig1s019,050761Orig1s016ltr.pdf
9/28/2015
AP
0
9/24/2015
SLR
44024
019
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/50542s02950754s01950760s01950761s016lbl.pdf
9/29/2015
AP
0
12/3/2015
SLR
44685
020
http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2015/050542Orig1s030,050754Orig1s020,050760Orig1s020,050761Orig1s017ltr.pdf
12/8/2015
AP
0
12/3/2015
SLR
44696
020
http://www.accessdata.fda.gov/drugsatfda_docs/label/2015/050542s030,050754s020,050760s020,050761s017lbl.pdf
12/8/2015
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