FDA.reportPublic FDA data

Application 216086

Type
ANDA
Sponsor
MSN LABORATORIES PRIVATE LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTINSITAGLIPTIN PHOSPHATETABLET; FILM COATED50MGNoNo
003SITAGLIPTINSITAGLIPTIN 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 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