FDA.reportPublic FDA data

Application 215411

Type
ANDA
Sponsor
INVENTIA HEALTHCARE LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTIN AND METFORMIN HYDROCHLORIDESITAGLIPTIN, METFORMIN HYDROCHLORIDETABLET50MGNoNo
003SITAGLIPTIN AND METFORMIN HYDROCHLORIDESITAGLIPTIN, METFORMIN HYDROCHLORIDETABLET500MGNoNo

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 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
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
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
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limitede07abcb1-1f0c-4cad-8405-8eedba4b8ff82025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Sitagliptin and metformin hydrochloride
Sitagliptin and metformin hydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Pharmaceuticals (USA) Inc.4d812277-21a8-4de3-b728-e3fdd01305b52025-06-09Boxed warning, Warnings, Adverse reactionsName fallback
brand 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
Sitagliptin and Metformin HydrochlorideSITAGLIPTIN AND METFORMIN HYDROCHLORIDEZydus Lifesciences Limiteda07fa1d9-7171-4f2a-ab34-f8fa410364a62024-08-24Name fallback
brand name: Sitagliptin and Metformin Hydrochloride