FDA.reportPublic FDA data

Application 219755

Type
ANDA
Sponsor
INVENTIA HEALTHCARE LIMITED

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE10MGNoNo
003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE5MGNoNo
004DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE500MGNoNo
005DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN, METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE2.5MGNoNo

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 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEGolden State Medical Supply, Inc.54027b70-53e7-3710-e063-6394a90aa04c2026-06-11Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin and Metformin Hydrochloride
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDELupin Pharmaceuticals, Inc.e6957674-86c1-4536-8e23-54ad7f2cacc42026-04-21Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDENovadoz Pharmaceuticals LLC4f890458-be94-4baf-b606-83a097e1e23e2026-04-09Boxed warning, Warnings, Adverse reactionsName fallback
brand name: DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
Dapagliflozin and Metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAurobindo Pharma Limited513bdf9f-774c-4f7f-935a-54d3885e80a42026-04-07Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin and Metformin hydrochloride
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEMacleods Pharmaceuticals Limited7d575ca8-9c1f-469d-a341-34daf2f036dd2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin and Metformin Hydrochloride
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2026-03-31Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Dapagliflozin and Metformin Hydrochloride
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEAscend Laboratories, LLCeadcc3ef-f5c2-4a56-a6aa-12909844144e2026-03-18Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dapagliflozin and metformin hydrochloride
dapagliflozin and metformin hydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEPrasco Laboratorieseaf135b6-e378-4f62-a1e7-db45e23668c72024-12-20Boxed warning, Warnings, Adverse reactionsName fallback
brand name: dapagliflozin and metformin hydrochloride