FDA.reportPublic FDA data

Application 020972

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SUSTIVAEFAVIRENZCAPSULE;ORAL50MGYesNo
002SUSTIVAEFAVIRENZCAPSULE;ORAL100MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003SUSTIVAEFAVIRENZCAPSULE;ORAL200MGYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0056-0470SUSTIVAEfavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0470SUSTIVAEfavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0470SUSTIVAEfavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0470SUSTIVAEfavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0470SUSTIVAEfavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0470SUSTIVAEfavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0474SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0474SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0474SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0474SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0474SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent
0056-0474SUSTIVAefavirenzBristol-Myers Squibb Pharma CompanyNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
76553SUPPL 2023-11-13
76545SUPPL 2023-11-09
60729SUPPL2019-10-30
60713SUPPL2019-10-30
50029SUPPL2017-10-12
50005SUPPL2017-10-11
47054SUPPL2017-01-31
47061SUPPL2017-01-30
45623SUPPL2016-10-17
45211SUPPL2016-08-31
45194SUPPL2016-08-31
35745SUPPL2016-04-01
26326SUPPL2016-04-01
35744SUPPL2015-04-02
26325SUPPL2015-04-01
35743SUPPL2014-05-28
26324SUPPL2014-05-27
35742SUPPL2013-05-21
3880SUPPL2013-05-07
35741SUPPL2012-08-15
26323SUPPL2012-08-15
14044SUPPL2012-06-26
3879SUPPL2012-06-26
3878SUPPL2011-12-21
35740SUPPL2011-12-19
26322SUPPL2011-09-29
14043SUPPL2011-09-26
51697SUPPL2011-07-18
3877SUPPL2010-12-03
35739SUPPL2010-11-29
26321SUPPL2010-04-05
14042SUPPL2010-04-04
51694SUPPL2009-12-23
26320SUPPL2009-11-10
35738SUPPL2009-10-01
14041SUPPL2009-04-23
26319SUPPL2009-03-12
35737SUPPL2008-08-26
26318SUPPL2008-08-20
51692SUPPL2008-01-31
21314SUPPL2007-07-20
41849SUPPL2007-07-18
41848SUPPL2007-07-18
14040SUPPL2007-02-05
35736SUPPL2007-02-02
3876SUPPL2007-02-02
3875SUPPL2006-04-05
26317SUPPL2005-04-28
14039SUPPL2005-04-28
51670SUPPL2005-02-28
14038SUPPL2004-11-01
3874SUPPL2004-10-29
26316SUPPL2004-08-25
14037SUPPL2004-08-25
26313SUPPL2004-06-18
21313SUPPL2004-03-10
14036SUPPL2003-12-01
26315SUPPL2003-11-26
51667SUPPL2003-07-02
26314SUPPL2003-06-22
14035SUPPL2003-06-22
14034SUPPL2003-06-22
3873SUPPL2003-06-22
14033SUPPL2003-04-25
35735SUPPL2003-01-29
3871SUPPL2003-01-29
3872SUPPL2002-09-20
3870SUPPL2002-03-01
51662SUPPL2001-08-08
35734SUPPL2000-02-09
51657SUPPL1999-09-17
35733ORIG1998-09-17
26312ORIG1998-09-17
21312ORIG1998-09-17
51648SUPPL1996-09-17
52447SUPPL1900-01-01
52446SUPPL1900-01-01