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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022044-001JANUMETMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-30
N022044-002JANUMETMETFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-30

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
N022044-001AB
N022044-002AB

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022044-00173267082026-11-24U-802Drug substance, Drug product
N022044-0017326708*PED2027-05-24Pediatric extension
N022044-00184149212028-07-21U-1036Drug product2013-04-09
N022044-0018414921*PED2029-01-21Pediatric extension
N022044-00273267082026-11-24U-802Drug substance, Drug product
N022044-0027326708*PED2027-05-24Pediatric extension
N022044-00284149212028-07-21U-1036Drug product
N022044-0028414921*PED2029-01-21Pediatric extension

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N022044-001JANUMET500MG;EQ 50MG BASETABLET / ORALABRLD2007-03-30a50c72e98297…
2026-08-01 22:54:322026-06N022044-002JANUMET1GM;EQ 50MG BASETABLET / ORALABRLD, RS2007-03-30a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06N022044-001AB1a50c72e98297…
2026-08-01 22:54:322026-06N022044-002AB1a50c72e98297…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-01 22:54:322026-06N022044-00173267082026-11-24U-802Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022044-0017326708*PED2027-05-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022044-00184149212028-07-21U-1036Drug product2013-04-09a50c72e98297…
2026-08-01 22:54:322026-06N022044-0018414921*PED2029-01-21Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022044-00273267082026-11-24U-802Drug substance, Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022044-0027326708*PED2027-05-24Pediatric extensiona50c72e98297…
2026-08-01 22:54:322026-06N022044-00284149212028-07-21U-1036Drug producta50c72e98297…
2026-08-01 22:54:322026-06N022044-0028414921*PED2029-01-21Pediatric extensiona50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022044
application number: NDA022044
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022044
application number: NDA022044
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 022044
application number: NDA022044
ndc (product): 0006-0575
ndc (product): 0006-0577

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

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 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
0006-0577JANUMETSITAGLIPTIN 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
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