FDA.reportPublic FDA data

Application 214859

Type
ANDA
Sponsor
AUROBINDO PHARMA LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTIN AND METFORMIN HYDROCHLORIDESITAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET500MGNoNo
003SITAGLIPTIN AND METFORMIN HYDROCHLORIDESITAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET1000MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 17 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.58f0e875-5d9b-be0b-e063-6394a90a53452026-08-13Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and Metformin Hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and metformin hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and metformin hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited0098dec4-f0e5-45d5-8aa4-5d0faf9ab1422026-08-12Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLC64beb3d2-3aeb-4cd5-ba11-dacf6c9a5b502026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEMerck Sharp & Dohme LLCd19c7ed0-ad5c-426e-b2df-722508f97d672026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ZITUVIMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.eeda90a0-4941-4716-8684-f9f12cbdf3af2026-07-15Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsc603b844-2019-4ef4-8385-7bc3f96a25652026-07-13Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
JANUMETSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutionsb55ee3d9-7f0b-4dd9-9213-fbc69f09f5672026-07-09Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEApotex Corp.950613e2-e959-6b57-e172-251ddc53c64c2026-04-14Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and Metformin Hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limited4bade493-499e-434a-97a0-26ca689176232026-01-05Name fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and Metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEPar Health USA, LLC43e3b1c9-3cbd-8dc3-e063-6394a90a10a22025-11-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and Metformin hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDESandoz Inca0fcdc08-0afc-4912-a126-3efea6bc8c612025-09-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and Metformin Hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
ZITUVIMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.2f635b36-e86a-4e53-8eaf-589917b5f3422025-07-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals USA Inc.d3a728a0-decb-4340-8ee4-c5e27c13eb192024-08-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and Metformin Hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda07fa1d9-7171-4f2a-ab34-f8fa410364a62024-08-24Name fallback
brand name: Sitagliptin and Metformin Hydrochloride
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE
JANUMET XRSITAGLIPTIN AND METFORMIN HYDROCHLORIDEA-S Medication Solutions90c0244b-afb3-4e69-b79f-486d002ca4322023-06-16Boxed warning, Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN AND METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.