FDA.reportPublic FDA data

Application 020579

Type
NDA
Sponsor
SANOFI AVENTIS US

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001FLOMAXTAMSULOSIN HYDROCHLORIDECAPSULE;ORAL0.4MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0024-5837FLOMAXtamsulosin hydrochloridesanofi-aventis U.S. LLCNDACurrent
0024-5837FLOMAXtamsulosin hydrochloridesanofi-aventis U.S. LLCNDACurrent
0024-5837FLOMAXtamsulosin hydrochloridesanofi-aventis U.S. LLCNDACurrent
0597-0058Flomaxtamsulosin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0058Flomaxtamsulosin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
0597-0058Flomaxtamsulosin hydrochlorideBoehringer Ingelheim Pharmaceuticals, Inc.NDACurrent
63629-3384Flomaxtamsulosin hydrochlorideBryant Ranch PrepackNDACurrent
63629-3384Flomaxtamsulosin hydrochlorideBryant Ranch PrepackNDACurrent
67296-1803FLOMAXtamsulosin hydrochlorideRedPharm Drug, Inc.NDACurrent
67296-1803FLOMAXtamsulosin hydrochlorideRedPharm Drug, Inc.NDACurrent
70518-0518Flomaxtamsulosin hydrochlorideREMEDYREPACK INC.NDACurrent
70518-0518Flomaxtamsulosin hydrochlorideREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57514SUPPL2019-02-13
57343SUPPL2019-01-25
2779SUPPL2014-10-22
34879SUPPL2014-10-21
34878SUPPL2014-07-24
25225SUPPL2014-07-24
12770SUPPL2011-07-27
2778SUPPL2011-07-27
41443ORIG2010-03-16
12769SUPPL2010-01-04
25224SUPPL2009-12-29
2777SUPPL2009-11-19
12768SUPPL2009-10-30
52931SUPPL2009-09-17
52930SUPPL2009-09-17
52929SUPPL2009-09-17
52355SUPPL2009-09-17
52354SUPPL2009-09-17
52353SUPPL2009-09-17
52352SUPPL2009-09-17
25223SUPPL2008-12-04
2776SUPPL2008-05-05
25222SUPPL2007-02-23
12767SUPPL2007-02-21
12766SUPPL2007-01-16
2775SUPPL2007-01-16
2774SUPPL2005-10-25
34877SUPPL2005-10-24