FDA.reportPublic FDA data

Application 208473

Type
ANDA
Sponsor
PRINSTON PHARMA INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;850MGNoNo
003LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN; METFORMIN HYDROCHLORIDETABLET;ORAL2.5MG;1GMNoNo

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
Linagliptin and metformin hydrochlorideLINAGLIPTIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC5cff87ef-97f9-4e3c-9e06-fd257f3cb3fb2025-11-04Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Linagliptin and metformin hydrochloride

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.