FDA.reportPublic FDA data

Application 211536

Type
ANDA
Sponsor
CIPLA LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;500MGNoNo
002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;500MGNoNo
003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL10MG;1GMNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A211536-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211536-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211536-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A211536-001AB
A211536-002AB
A211536-003AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A211536-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211536-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-09-14 22:38:342026-08A211536-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-0684e616aacf4f…
2026-08-18 06:07:402026-07A211536-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211536-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-08-18 06:07:402026-07A211536-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211536-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211536-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211536-003DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A211536-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A211536-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A211536-003AB184e616aacf4f…
2026-08-18 06:07:402026-07A211536-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211536-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A211536-003AB1caaa826d4ba7…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211536-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211536-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211536-003AB1a50c72e98297…

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 · 5 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 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 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

Reported adverse events (FAERS/openFDA)#

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