FDA.reportPublic FDA data

Application 220511

Type
ANDA
Sponsor
AJANTA PHARMA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEEMPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE5MG/1000MGNoNo
002EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEEMPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE10MG/1000MGNoNo
003EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEEMPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE12.5MG/1000MGNoNo
004EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEEMPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE25MG/1000MGNoNo

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
Synjardy XREMPAGLIFLOZIN, METFORMIN HYDROCHLORIDEBoehringer Ingelheim Pharmaceuticals, Inc.8006ba29-ee3a-f852-a9bb-c8ec9b41cf662026-08-11Boxed warning, Warnings, Adverse reactionsName fallback
generic name: EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

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