FDA.reportPublic FDA data

Application 214700

Type
ANDA
Sponsor
DR REDDYS LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET;FILM COATED25MGNoNo
002SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET;FILM COATED50MGNoNo
003SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET;FILM COATED100MGNoNo

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