Application 021410

Type
NDA
Sponsor
SB PHARMCO

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AVANDAMETMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL500MG;EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002AVANDAMETMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL500MG;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003AVANDAMETMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL500MG;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
004AVANDAMETMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL1GM;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
005AVANDAMETMETFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATETABLET;ORAL1GM;EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
47950SUPPL2017-04-12
47932SUPPL2017-04-11
47929SUPPL2017-04-11
5289SUPPL2015-12-17
36850SUPPL2014-05-12
15397SUPPL2014-05-12
15396SUPPL2014-05-12
27701SUPPL2014-05-08
27700SUPPL2014-05-08
5288SUPPL2014-05-08
5287SUPPL2013-09-19
27699SUPPL2013-01-30
36849SUPPL2012-06-06
5286SUPPL2012-06-04
27698SUPPL2011-11-21
15395SUPPL2011-11-16
27697SUPPL2011-05-24
15394SUPPL2011-05-17
36848SUPPL2011-02-04
5285SUPPL2011-02-03
42141SUPPL2009-09-14
15393SUPPL2008-12-04
5284SUPPL2008-12-04
23655ORIG2008-02-21
15392SUPPL2007-09-26
27696SUPPL2007-09-25
36847SUPPL2007-08-22
5283SUPPL2007-08-22
5282SUPPL2007-05-01
36846SUPPL2007-04-25
27695SUPPL2007-02-12
15391SUPPL2007-02-02
36844SUPPL2006-05-22
5280SUPPL2006-05-22
5281SUPPL2006-04-21
36845SUPPL2006-04-20
5279SUPPL2005-03-01
36843SUPPL2005-01-11
36842SUPPL2004-05-27
15390SUPPL2004-05-27
27694SUPPL2004-05-26
5278SUPPL2004-05-26
15389SUPPL2003-08-28
5277SUPPL2003-08-28
42140ORIG2003-04-30
36841ORIG2002-10-10
27693ORIG2000-05-09