FDA.reportPublic FDA data

Application 205959

Type
ANDA
Sponsor
PAR PHARM

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002SAXAGLIPTINSAXAGLIPTINTABLET;ORAL5MGNoNo

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 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAXAGLIPTINSAXAGLIPTINGlenmark Pharmaceuticals Inc., USAe286ffd4-c598-47fb-af06-2e15f7e6f99f2026-01-27Warnings, Adverse reactionsName fallback
brand name: SAXAGLIPTIN
generic name: SAXAGLIPTIN
SaxagliptinSAXAGLIPTINMylan Pharmaceuticals Inc.6e8d8c4f-96eb-4b64-9c8c-4a5448a23a782025-02-28Warnings, Adverse reactionsName fallback
brand name: Saxagliptin
generic name: SAXAGLIPTIN
SaxagliptinSAXAGLIPTINAurobindo Pharma Limitedf3ea58bb-0002-4a5d-9213-7e9066e3dc9c2024-12-04Warnings, Adverse reactionsName fallback
brand name: Saxagliptin
generic name: SAXAGLIPTIN

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
45085ORIG2016-08-22