FDA.reportPublic FDA data

Application 218441

Type
ANDA
Sponsor
BIOCON PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SITAGLIPTINSITAGLIPTINTABLET50MGNoNo
003SITAGLIPTINSITAGLIPTINTABLET100MGNoNo

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 15 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
JANUVIASITAGLIPTINA-S Medication Solutions62c4f58b-2b28-4825-aeb6-213ab9b7a0262026-07-08Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINA-S Medication Solutions194c3718-5eb5-4cf5-85d0-2bb1ed8293b82026-07-08Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINA-S Medication Solutions4a758211-8af1-449b-9a10-f3d67d7ec8b62026-07-08Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINA-S Medication Solutions1b03c82f-b52e-4092-b9dc-f2c9b0d6ab402026-07-08Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINA-S Medication Solutionseb81a45f-05b8-49de-99ce-5089bd360d9b2026-07-08Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
SitagliptinSITAGLIPTINApotex Corp.983e9e14-e9bd-3136-e573-98b4dc67860b2026-04-14Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
generic name: SITAGLIPTIN
SitagliptinSITAGLIPTINTeva Pharmaceuticals, Inc.5fa5aa67-455e-4ac6-864d-268a912864322025-12-01Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINCardinal Health 107, LLC9d558f96-24a5-4788-8933-38256c17384b2025-11-05Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINCardinal Health 107, LLC39253ddd-0245-43b1-ad28-d5923983afb42025-11-05Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
ZITUVIOSITAGLIPTINZydus Pharmaceuticals (USA) Inc.abfdea45-c0ca-41e3-a510-e89810bc9cfe2025-01-31Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
ZITUVIOSITAGLIPTINZydus Lifesciences Limitedb2da9d77-154b-48f7-8793-3f4a24dfafc62025-01-31Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
SitagliptinSITAGLIPTINZydus Pharmaceuticals (USA) Inc.6a970e80-b753-48fa-9fff-87e7a50449822025-01-31Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
generic name: SITAGLIPTIN
SitagliptinSITAGLIPTINZydus Lifesciences Limitede5ac97e8-3a0b-4750-8e3f-3374125707462025-01-31Warnings, Adverse reactionsName fallback
brand name: Sitagliptin
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINMerck Sharp & Dohme LLCf85a48d0-0407-4c50-b0fa-7673a160bf012024-11-14Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN
JANUVIASITAGLIPTINA-S Medication Solutionse2e576e6-6181-4178-b989-61d0e795e5592024-01-31Warnings, Adverse reactionsName fallback
generic name: SITAGLIPTIN