FDA.reportPublic FDA data

Application 021567

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001REYATAZATAZANAVIR SULFATECAPSULE;ORALEQ 100MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002REYATAZATAZANAVIR SULFATECAPSULE;ORALEQ 150MG BASEYesNo
003REYATAZATAZANAVIR SULFATECAPSULE;ORALEQ 200MG BASEYesNo
004REYATAZATAZANAVIR SULFATECAPSULE;ORALEQ 300MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0003-3622REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3622REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3622REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3622REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3622REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3624REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3624REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3624REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3624REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3624REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3631REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3631REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3631REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3631REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
0003-3631REYATAZATAZANAVIRE.R. Squibb & Sons, L.L.C.NDACurrent
50090-1007REYATAZATAZANAVIRA-S Medication SolutionsNDACurrent
50090-1581REYATAZATAZANAVIRA-S Medication SolutionsNDACurrent
59762-0408ATAZANAVIRATAZANAVIRGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0409ATAZANAVIRATAZANAVIRGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0410ATAZANAVIRATAZANAVIRGreenstone LLCNDA AUTHORIZED GENERICCurrent
59762-0410ATAZANAVIRATAZANAVIRGreenstone LLCNDA AUTHORIZED GENERICCurrent
67296-1236REYATAZREYATAZRedPharm Drug, Inc.NDACurrent
67296-1236REYATAZREYATAZRedPharm Drug, Inc.NDACurrent
67296-1236REYATAZREYATAZRedPharm Drug, Inc.NDACurrent
69189-3624REYATAZATAZANAVIRAvera McKennan HospitalNDACurrent
69189-3631REYATAZATAZANAVIRAvera McKennan HospitalNDACurrent
70518-0469REYATAZATAZANAVIRREMEDYREPACK INC.NDACurrent
70518-0469REYATAZATAZANAVIRREMEDYREPACK INC.NDACurrent
70518-0688REYATAZATAZANAVIRREMEDYREPACK INC.NDACurrent
70518-0688REYATAZATAZANAVIRREMEDYREPACK INC.NDACurrent
70518-0725REYATAZATAZANAVIRREMEDYREPACK INC.NDACurrent
70518-0725REYATAZATAZANAVIRREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
80540SUPPL 2024-12-10
80530SUPPL 2024-12-06
76536SUPPL 2023-11-08
76524SUPPL 2023-11-08
74201SUPPL 2023-05-10
64688SUPPL2020-09-25
64680SUPPL2020-09-25
53767SUPPL2018-04-20
53740SUPPL2018-04-19
50165SUPPL2017-10-24
50140SUPPL2017-10-23
48542SUPPL2017-05-25
48528SUPPL2017-05-25
45337SUPPL2016-09-20
45307SUPPL2016-09-15
37246SUPPL2015-12-10
28143SUPPL2015-09-28
42214SUPPL2015-07-20
24206SUPPL2015-04-07
21737SUPPL2015-04-07
15793SUPPL2015-04-02
28142SUPPL2015-04-01
5751SUPPL2015-02-27
21736SUPPL2014-08-05
28141SUPPL2014-06-03
15792SUPPL2014-06-03
37245SUPPL2013-08-21
15791SUPPL2013-08-21
28140SUPPL2013-08-20
5750SUPPL2013-08-20
51255SUPPL2013-05-20
28139SUPPL2013-02-04
51254SUPPL2013-01-29
28138SUPPL2012-03-16
15790SUPPL2012-03-16
37244SUPPL2012-02-24
5749SUPPL2012-02-23
51253SUPPL2011-11-22
28137SUPPL2011-10-19
37243SUPPL2011-10-17
51248SUPPL2011-08-02
28136SUPPL2011-02-10
15789SUPPL2011-02-09
37242SUPPL2010-05-03
5748SUPPL2010-04-29
28135SUPPL2010-01-28
28134SUPPL2010-01-25
37241SUPPL2010-01-24
15788SUPPL2009-11-23
51252SUPPL2009-04-29
37240SUPPL2008-10-03
28132SUPPL2008-10-02
37239SUPPL2008-08-26
5747SUPPL2008-08-20
51251SUPPL2008-05-01
28131SUPPL2008-03-28
37238SUPPL2008-03-27
15787SUPPL2008-02-25
28133SUPPL2008-02-22
28130SUPPL2008-01-09
15786SUPPL2008-01-08
37237SUPPL2007-03-31
28129SUPPL2007-03-31
51250SUPPL2006-12-04
5746SUPPL2006-10-23
37236SUPPL2006-10-18
28128SUPPL2006-08-14
28127SUPPL2006-08-14
37235SUPPL2006-08-11
15785SUPPL2006-08-11
28126SUPPL2006-01-30
37234SUPPL2006-01-25
28125SUPPL2005-07-21
15784SUPPL2005-07-21
37233SUPPL2004-10-08
5745SUPPL2004-10-08
15783SUPPL2004-07-07
5744SUPPL2004-07-07
37232SUPPL2004-04-05
5743SUPPL2004-03-19
42213ORIG2003-09-09
51249SUPPL2003-08-25
5742ORIG2003-08-06
37231ORIG2003-07-08
67191SUPPL1900-01-01
67190SUPPL1900-01-01
63866ORIG1900-01-01
63865ORIG1900-01-01
63864ORIG1900-01-01
63863ORIG1900-01-01
63862ORIG1900-01-01
63861ORIG1900-01-01
63860ORIG1900-01-01
63859ORIG1900-01-01
54095SUPPL1900-01-01
54094SUPPL1900-01-01
51747SUPPL1900-01-01
51746SUPPL1900-01-01
51743SUPPL1900-01-01
51742SUPPL1900-01-01