FDA.reportPublic FDA data

Application 021071

Type
NDA
Sponsor
SB PHARMCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002AVANDIAROSIGLITAZONE MALEATETABLET;ORALEQ 2MG BASEYesNo
003AVANDIAROSIGLITAZONE MALEATETABLET;ORALEQ 4MG BASEYesNo
004AVANDIAROSIGLITAZONE MALEATETABLET;ORALEQ 8MG BASEYesNo

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0861AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent
0173-0863AVANDIArosiglitazone maleateGlaxoSmithKline LLCNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57600SUPPL2019-02-14
57494SUPPL2019-02-07
57493SUPPL2019-02-07
45381SUPPL2016-09-21
45354SUPPL2016-09-21
26637SUPPL2015-12-17
36012SUPPL2014-05-12
36011SUPPL2014-05-12
14283SUPPL2014-05-12
26636SUPPL2014-05-08
26635SUPPL2014-05-08
4203SUPPL2014-05-08
44993SUPPL2014-05-07
4202SUPPL2013-09-19
4201SUPPL2013-01-30
14282SUPPL2012-06-06
4200SUPPL2012-06-04
4199SUPPL2011-11-21
36010SUPPL2011-11-16
26634SUPPL2011-05-24
36009SUPPL2011-05-17
36008SUPPL2011-02-04
4198SUPPL2011-02-03
41921SUPPL2009-09-14
14281SUPPL2008-10-31
26633SUPPL2008-10-21
26630SUPPL2008-07-14
14279SUPPL2008-07-14
36007SUPPL2008-02-25
26632SUPPL2008-02-25
44092ORIG2008-02-21
36005SUPPL2008-01-18
4196SUPPL2008-01-18
36006SUPPL2007-11-19
4197SUPPL2007-11-19
14280SUPPL2007-09-26
4195SUPPL2007-09-25
26631SUPPL2007-08-17
36004SUPPL2007-08-15
21406SUPPL2007-07-27
26629SUPPL2007-05-01
36003SUPPL2007-04-25
36002SUPPL2006-06-20
26628SUPPL2006-06-20
14278SUPPL2006-06-20
4194SUPPL2006-06-20
36001SUPPL2006-04-25
4193SUPPL2006-04-25
26627SUPPL2005-08-03
14277SUPPL2005-08-03
14274SUPPL2005-05-17
4191SUPPL2005-05-17
26626SUPPL2005-03-03
14275SUPPL2005-03-03
14276SUPPL2005-01-11
4192SUPPL2005-01-11
21405SUPPL2004-05-27
21404ORIG2004-05-27
4190SUPPL2004-05-26
26625SUPPL2003-03-10
36000SUPPL2003-02-27
4189SUPPL2002-12-03
35999SUPPL2000-04-04
26624SUPPL2000-04-04
35998ORIG1999-05-25
26623ORIG1999-05-25
63740SUPPL1900-01-01
52185SUPPL1900-01-01
52184SUPPL1900-01-01
52183SUPPL1900-01-01
52182SUPPL1900-01-01
52180SUPPL1900-01-01