Application 020938

Type
NDA
Sponsor
BOEHRINGER INGELHEIM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001MOBICMELOXICAMTABLET;ORAL7.5MGYesNo
002MOBICMELOXICAMTABLET;ORAL15MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0029MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0030MobicmeloxicamBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
55289-618MobicmeloxicamPD-Rx Pharmaceuticals, Inc.NDACurrent
70518-1580MobicmeloxicamREMEDYREPACK INC.NDACurrent
70518-1580MobicmeloxicamREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80381SUPPL 2024-11-25
80380SUPPL 2024-11-25
80283SUPPL 2024-11-22
67353SUPPL2021-05-03
67352SUPPL2021-05-03
67264SUPPL2021-04-30
35685SUPPL2016-07-05
26256SUPPL2016-07-01
26255SUPPL2016-05-12
26254SUPPL2016-05-12
35684SUPPL2016-05-11
13786SUPPL2016-05-11
3811SUPPL2012-03-12
35683SUPPL2012-03-05
35682SUPPL2011-08-05
26253SUPPL2011-08-05
26252SUPPL2010-08-03
13785SUPPL2010-08-01
26251SUPPL2010-04-29
13784SUPPL2010-04-28
23208ORIG2009-11-19
3810SUPPL2008-07-01
13783SUPPL2008-06-30
35681SUPPL2007-02-02
26250SUPPL2007-02-02
35680SUPPL2005-08-15
26249SUPPL2005-08-15
13782SUPPL2005-08-15
3809SUPPL2005-08-15
35679SUPPL2004-07-21
3808SUPPL2004-07-21
26248SUPPL2003-05-29
13781SUPPL2003-05-06
21291ORIG2001-07-18
35678ORIG2000-04-13
26247ORIG2000-04-13
52030SUPPL1900-01-01
52029SUPPL1900-01-01
52026SUPPL1900-01-01