FDA.reportPublic FDA data

Application 217041

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

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTINSITAGLIPTIN PHOSPHATETABLET50MGNoNo
003SITAGLIPTINSITAGLIPTIN PHOSPHATETABLET100MGNoNo

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sitagliptin PhosphateSITAGLIPTIN PHOSPHATESandoz Inccebc8388-c9db-4e27-8d6b-0d9bdc9d766d2026-05-10Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN PHOSPHATE
SitagliptinSITAGLIPTINApotex Corp.983e9e14-e9bd-3136-e573-98b4dc67860b2026-04-14Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
SitagliptinSITAGLIPTINTeva Pharmaceuticals, Inc.5fa5aa67-455e-4ac6-864d-268a912864322025-12-01Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
SitagliptinSITAGLIPTINZydus Pharmaceuticals (USA) Inc.6a970e80-b753-48fa-9fff-87e7a50449822025-01-31Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
SitagliptinSITAGLIPTINZydus Lifesciences Limitede5ac97e8-3a0b-4750-8e3f-3374125707462025-01-31Warnings, Adverse reactionsName fallback
brand name: Sitagliptin