Application 021700

Type
NDA
Sponsor
SB PHARMCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVANDARYLGLIMEPIRIDE; ROSIGLITAZONE MALEATETABLET;ORAL1MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002AVANDARYLGLIMEPIRIDE; ROSIGLITAZONE MALEATETABLET;ORAL2MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003AVANDARYLGLIMEPIRIDE; ROSIGLITAZONE MALEATETABLET;ORAL4MG;4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004AVANDARYLGLIMEPIRIDE; ROSIGLITAZONE MALEATETABLET;ORAL2MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005AVANDARYLGLIMEPIRIDE; ROSIGLITAZONE MALEATETABLET;ORAL4MG;8MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
56230SUPPL2018-11-01
28411SUPPL2015-12-17
37487SUPPL2015-03-19
28410SUPPL2015-03-17
37486SUPPL2014-05-12
37485SUPPL2014-05-12
16225SUPPL2014-05-12
28409SUPPL2014-05-08
28408SUPPL2014-05-08
6019SUPPL2014-05-08
6018SUPPL2013-09-19
6017SUPPL2013-01-30
37484SUPPL2012-06-06
6016SUPPL2012-06-04
6015SUPPL2011-11-21
16224SUPPL2011-11-16
6014SUPPL2011-05-24
16223SUPPL2011-05-17
16222SUPPL2011-02-04
6013SUPPL2011-02-03
37483SUPPL2009-12-10
37482SUPPL2008-12-04
28407SUPPL2008-12-04
44144ORIG2008-02-21
28405SUPPL2007-09-25
37481SUPPL2007-08-22
28406SUPPL2007-08-22
42275ORIG2007-07-02
28404SUPPL2007-04-09
28403SUPPL2006-10-26
37480SUPPL2006-10-25
37479SUPPL2006-06-20
28402SUPPL2006-06-20
16221SUPPL2006-06-20
6012SUPPL2006-06-20
37478ORIG2005-11-30
6011ORIG2005-11-30