FDA.reportPublic FDA data

Application 202270

Type
NDA
Sponsor
MERCK SHARP DOHME

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET, EXTENDED RELEASE;ORAL500MG;EQ 50MG BASEYesNo
002JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET, EXTENDED RELEASE;ORAL1GM;EQ 50MG BASEYesNo
003JANUMET XRMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATETABLET, EXTENDED RELEASE;ORAL1GM;EQ 100MG BASEYesYes

NDC Listings For This Application#

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0078JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0080JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme LLCNDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
0006-0081JANUMETsitagliptin and metformin hydrochlorideMerck Sharp & Dohme Corp.NDACurrent
50090-4411JANUMETsitagliptin and metformin hydrochlorideA-S Medication SolutionsNDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
71438SUPPL2022-06-24
71437SUPPL2022-06-24
71427SUPPL2022-06-22
69273SUPPL2021-11-08
69262SUPPL2021-11-05
65546SUPPL2020-12-09
65522SUPPL2020-12-08
65501SUPPL2020-12-04
59690SUPPL2019-08-13
59682SUPPL2019-08-13
59282SUPPL2019-07-09
59209SUPPL2019-07-02
52635SUPPL2018-02-14
52561SUPPL2018-02-12
52556SUPPL2018-02-12
49407SUPPL2017-08-15
49352SUPPL2017-08-14
46933SUPPL2017-01-24
46932SUPPL2017-01-24
46925SUPPL2017-01-18
46924SUPPL2017-01-18
19309SUPPL2015-09-04
32222SUPPL2015-09-01
40155SUPPL2015-05-04
10010SUPPL2015-04-29
40154SUPPL2014-02-13
32221SUPPL2014-02-13
43392ORIG2013-09-03
24412ORIG2013-09-03
10009SUPPL2013-02-13
40153SUPPL2013-02-11
19308SUPPL2012-10-22
10008SUPPL2012-10-22
19307ORIG2012-02-06
10007ORIG2012-02-06