FDA.reportPublic FDA data

Application 202423

Type
ANDA
Sponsor
SUN PHARMA GLOBAL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET; ORAL25MGNoNo
002SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET; ORAL50MGNoNo
003SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET; ORAL100MGNoNo

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 1 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
brand name: Sitagliptin Phosphate
generic name: SITAGLIPTIN PHOSPHATE