FDA.reportPublic FDA data

Application 021087

Type
NDA
Sponsor
ROCHE

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001TAMIFLUOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 75MG BASEYesYes
002TAMIFLUOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 45MG BASEYesNo
003TAMIFLUOSELTAMIVIR PHOSPHATECAPSULE;ORALEQ 30MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0004-0800Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0800Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0800Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0800Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0800Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0801Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0801Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0801Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0801Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0801Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0802Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0802Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0802Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0802Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
0004-0802Tamifluoseltamivir phosphateGenentech, Inc.NDACurrent
42254-001Tamifluoseltamivir phosphateRebel Distributors CorpNDACurrent
50090-0662Tamifluoseltamivir phosphateA-S Medication SolutionsNDACurrent
50090-0662Tamifluoseltamivir phosphateA-S Medication SolutionsNDACurrent
50090-0662Tamifluoseltamivir phosphateA-S Medication SolutionsNDACurrent
55045-2759Tamifluoseltamivir phosphateDispensing Solutions, Inc.NDACurrent
70518-2042Tamifluoseltamivir phosphateREMEDYREPACK INC.NDACurrent
70518-2042Tamifluoseltamivir phosphateREMEDYREPACK INC.NDACurrent
70518-2042Tamifluoseltamivir phosphateREMEDYREPACK INC.NDACurrent
70518-2042Tamifluoseltamivir phosphateREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
59576SUPPL2019-08-05
59570SUPPL2019-08-05
56806SUPPL2018-12-19
56796SUPPL2018-12-19
53667SUPPL2018-04-13
53629SUPPL2018-04-06
26749SUPPL2016-06-22
36101SUPPL2016-06-21
41947SUPPL2015-07-21
41948SUPPL2015-07-20
36098SUPPL2014-12-03
4310SUPPL2014-11-28
26748SUPPL2014-10-16
14373SUPPL2014-10-15
41946SUPPL2014-07-07
36100SUPPL2014-06-03
4313SUPPL2014-06-03
44471SUPPL2013-08-12
14372SUPPL2013-08-12
21443SUPPL2013-06-03
21442SUPPL2013-06-03
21444SUPPL2013-04-08
4311SUPPL2013-01-29
44637SUPPL2012-12-21
36099SUPPL2012-12-21
4312SUPPL2012-12-21
26747SUPPL2012-08-20
14371SUPPL2012-08-17
4309SUPPL2011-03-24
14370SUPPL2011-03-23
26746SUPPL2011-02-09
36097SUPPL2011-02-07
26742SUPPL2010-12-21
14367SUPPL2010-12-16
26745SUPPL2010-11-10
14369SUPPL2010-11-05
36096SUPPL2010-03-03
14368SUPPL2010-03-03
26744SUPPL2010-02-26
4308SUPPL2010-02-26
26727SUPPL2009-11-05
26725SUPPL2009-11-05
4295SUPPL2009-11-05
26738SUPPL2009-10-21
26737SUPPL2009-10-21
26736SUPPL2009-10-21
26734SUPPL2009-10-21
26741SUPPL2009-10-19
26735SUPPL2009-10-19
26733SUPPL2009-10-19
26731SUPPL2009-10-19
26730SUPPL2009-10-19
26729SUPPL2009-10-19
26728SUPPL2009-10-19
4307SUPPL2009-10-19
4304SUPPL2009-10-19
4302SUPPL2009-10-19
4301SUPPL2009-10-19
4297SUPPL2009-10-19
4296SUPPL2009-10-16
36095SUPPL2009-04-29
26743SUPPL2009-04-29
36094SUPPL2008-01-18
26740SUPPL2008-01-18
4306SUPPL2007-12-18
36093SUPPL2007-10-10
26739SUPPL2007-10-10
36092SUPPL2007-07-05
4305SUPPL2007-07-05
41945SUPPL2007-06-22
41944SUPPL2007-06-22
41943SUPPL2007-06-22
41942SUPPL2007-06-22
41941SUPPL2007-06-22
21441SUPPL2007-06-22
21440SUPPL2007-06-22
21439SUPPL2007-06-22
21438SUPPL2007-06-22
21437SUPPL2007-06-18
21436SUPPL2007-06-18
21434SUPPL2007-06-18
44094ORIG2006-12-13
26732SUPPL2006-11-16
43568SUPPL2006-11-14
14366SUPPL2006-11-14
4303SUPPL2006-01-18
23066SUPPL2006-01-10
14365SUPPL2006-01-10
14363SUPPL2005-11-01
4299SUPPL2005-11-01
14364SUPPL2005-08-19
4300SUPPL2005-08-19
36091SUPPL2005-04-28
4298SUPPL2005-04-28
26726SUPPL2004-07-01
14362SUPPL2004-07-01
21435SUPPL2004-04-14
36089SUPPL2003-04-22
36090SUPPL2002-04-26
26724SUPPL2002-04-26