Application 021178

Type
NDA
Sponsor
BRISTOL MYERS SQUIBB

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001GLUCOVANCEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL1.25MG;250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
002GLUCOVANCEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo
003GLUCOVANCEGLYBURIDE; METFORMIN HYDROCHLORIDETABLET;ORAL5MG;500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**YesNo

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
57105SUPPL2019-01-02
57061SUPPL2018-12-30
47954SUPPL2017-04-12
47953SUPPL2017-04-12
47925SUPPL2017-04-11
47924SUPPL2017-04-11
36295SUPPL2013-10-22
4568SUPPL2013-10-16
14582SUPPL2010-12-01
4567SUPPL2010-11-30
36294SUPPL2009-12-02
36293SUPPL2008-09-19
4566SUPPL2008-09-17
27000SUPPL2006-12-28
14581SUPPL2006-12-26
14580SUPPL2004-04-05
26999SUPPL2004-03-19
21490ORIG2003-12-31
21491SUPPL2003-10-29
26998SUPPL2002-09-30
14579SUPPL2002-09-30
36292ORIG2000-07-31
4565ORIG2000-07-31
51974SUPPL1900-01-01
51973SUPPL1900-01-01
51972SUPPL1900-01-01
51971SUPPL1900-01-01
51970SUPPL1900-01-01
51969SUPPL1900-01-01
51968SUPPL1900-01-01