FDA.reportPublic FDA data

Application 208454

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET; ORAL2.5MG/500MGNoNo
002LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN AND METFORMIN HYDROCHLORIDETABLET; ORAL2.5MG/850MGNoNo
003LINAGLIPTIN AND METFORMIN HYDROCHLORIDELINAGLIPTIN AND 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 3 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
generic name: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
JentaduetoLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.f6dd9b86-0d18-95d4-2bc7-05591bfdd5972024-06-27Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE
Jentadueto XRLINAGLIPTIN AND METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.3d02a4d4-d312-80b4-05c4-691b8f0aa7aa2024-05-24Boxed warning, Warnings, Adverse reactionsName fallback
generic name: LINAGLIPTIN AND METFORMIN HYDROCHLORIDE

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
63458ORIG2020-06-09