FDA.reportPublic FDA data

Application 021360

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUSTIVAEFAVIRENZTABLET;ORAL300MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002SUSTIVAEFAVIRENZTABLET;ORAL600MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0056-0510SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0510SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0510SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0510SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0510SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0510SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
70518-0482SUSTIVAefavirenzREMEDYREPACK INC.NDACurrent
70518-0482SUSTIVAefavirenzREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76552SUPPL 2023-11-13
76544SUPPL 2023-11-09
60730SUPPL2019-10-30
60712SUPPL2019-10-30
50030SUPPL2017-10-12
50004SUPPL2017-10-11
47053SUPPL2017-01-31
47060SUPPL2017-01-30
45624SUPPL2016-10-17
45212SUPPL2016-08-31
45193SUPPL2016-08-31
36759SUPPL2016-04-01
5172SUPPL2016-04-01
15299SUPPL2015-04-02
5171SUPPL2015-04-01
36758SUPPL2014-05-28
27594SUPPL2014-05-27
5170SUPPL2013-05-07
15298SUPPL2013-05-03
27593SUPPL2012-08-15
15297SUPPL2012-08-15
15296SUPPL2012-06-26
5169SUPPL2012-06-26
5168SUPPL2011-12-21
36757SUPPL2011-12-19
5167SUPPL2011-09-29
36756SUPPL2011-09-27
5166SUPPL2010-12-03
15295SUPPL2010-11-29
5165SUPPL2010-04-05
15294SUPPL2010-04-04
27592SUPPL2009-11-10
15293SUPPL2009-10-01
15292SUPPL2009-04-23
5164SUPPL2009-03-12
36755SUPPL2008-08-26
27591SUPPL2008-08-20
42118SUPPL2007-07-20
21618SUPPL2007-07-20
27590SUPPL2007-02-05
15291SUPPL2007-02-05
36754SUPPL2007-02-02
5163SUPPL2007-02-02
36753SUPPL2005-04-28
5162SUPPL2005-04-28
15290SUPPL2004-11-01
27589SUPPL2004-10-29
27588SUPPL2004-08-25
15289SUPPL2004-08-25
36752SUPPL2003-12-01
27587SUPPL2003-11-26
27586SUPPL2003-06-22
27585SUPPL2003-06-22
15288SUPPL2003-06-22
15287SUPPL2003-06-22
5161SUPPL2002-09-20
21617ORIG2002-05-15
36751ORIG2002-02-01
27584ORIG2002-02-01