FDA.reportPublic FDA data

Application 219296

Type
ANDA
Sponsor
FOSUN WANBANG (JIANGSU) PHARMACEUTICAL GROUP CO.,

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE, SITAGLIPTINTABLET, EXTENDED RELEASEEQ 100MG BASE TABLETNoNo
003SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE, SITAGLIPTINTABLET, EXTENDED RELEASE500MGNoNo
004SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE, SITAGLIPTINTABLET, EXTENDED RELEASE50MGNoNo
005SITAGLIPTIN AND METFORMIN HYDROCHLORIDEMETFORMIN HYDROCHLORIDE, SITAGLIPTINTABLET, EXTENDED RELEASE1000MGNoNo

Source provenance: Browse the complete Orange Book source catalog.

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 · 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