FDA.reportPublic FDA data

Application 022044

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JANUMETMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET;ORAL500MG;EQ 50MG BASEYesNo
002JANUMETMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET;ORAL1GM;EQ 50MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCNDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCNDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0575JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCNDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCNDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
0006-0577JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEMerck Sharp & Dohme Corp.NDACurrent
50090-5618JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEA-S Medication SolutionsNDACurrent
70518-2548JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEREMEDYREPACK INC.NDACurrent
70518-2548JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEREMEDYREPACK INC.NDACurrent
70518-2548JANUMETSITAGLIPTIN and METFORMIN HYDROCHLORIDEREMEDYREPACK INC.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71440SUPPL2022-06-24
71439SUPPL2022-06-24
71426SUPPL2022-06-22
69428SUPPL2021-12-01
69261SUPPL2021-11-05
65547SUPPL2020-12-09
65521SUPPL2020-12-08
65502SUPPL2020-12-04
59689SUPPL2019-08-13
59688SUPPL2019-08-13
59683SUPPL2019-08-13
59281SUPPL2019-07-09
59280SUPPL2019-07-09
59208SUPPL2019-07-02
52634SUPPL2018-02-14
52559SUPPL2018-02-12
52555SUPPL2018-02-12
49406SUPPL2017-08-15
49350SUPPL2017-08-14
46944SUPPL2017-01-24
46943SUPPL2017-01-24
46923SUPPL2017-01-18
46922SUPPL2017-01-18
38134SUPPL2015-09-04
29138SUPPL2015-09-01
38133SUPPL2015-05-04
29137SUPPL2015-04-29
29136SUPPL2013-09-24
38132SUPPL2013-09-17
44168ORIG2013-04-29
38131SUPPL2013-02-08
29135SUPPL2013-02-08
16828SUPPL2012-10-22
6757SUPPL2012-10-22
29134SUPPL2012-03-27
16827SUPPL2012-03-27
6753SUPPL2011-06-17
16825SUPPL2011-05-16
6754SUPPL2011-05-16
6755SUPPL2011-04-19
16824SUPPL2011-04-18
38130SUPPL2010-09-29
29133SUPPL2010-09-29
16826SUPPL2010-09-29
6756SUPPL2010-09-29
29132SUPPL2010-03-04
6752SUPPL2010-03-04
6750SUPPL2010-03-04
38129SUPPL2010-03-02
16823SUPPL2010-03-02
16822SUPPL2010-03-02
6751SUPPL2010-01-14
38128SUPPL2009-12-31
29131SUPPL2008-10-23
21916ORIG2008-07-08
6749SUPPL2008-05-07
29129SUPPL2008-02-29
6747SUPPL2008-02-29
38126SUPPL2008-02-28
38125SUPPL2008-02-28
29130SUPPL2008-01-09
6748SUPPL2008-01-09
6746SUPPL2008-01-09
38127SUPPL2008-01-08
16821SUPPL2008-01-08
16820SUPPL2008-01-08
29128ORIG2007-04-09
16819ORIG2007-04-06