FDA.reportPublic FDA data

Application 215155

Type
ANDA
Sponsor
ALKEM LABS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET;ORALEQ 50MG BASENoNo
003SITAGLIPTIN PHOSPHATESITAGLIPTIN PHOSPHATETABLET;ORALEQ 100MG BASENoNo

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

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
85403ORIG 2026-03-19