FDA.reportPublic FDA data

Application 211491

Type
ANDA
Sponsor
SUN PHARM INDS LTD

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDETABLET, EXTENDED RELEASE;ORAL5MG;1GMNoNo
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 1.

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
A211491-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211491-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDEDAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06
A211491-003DAPAGLIFLOZIN 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
A211491-001AB
A211491-002AB
A211491-003AB

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
A211491-001PC2026-10-03
A211491-002PC2026-10-03
A211491-003PC2026-10-03

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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-001DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE5MG;1GMTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-002DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE10MG;500MGTABLET, EXTENDED RELEASE / ORALAB2026-04-06a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-003DAPAGLIFLOZIN 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
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-001AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-002AB1a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-003AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-001PC2026-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-002PC2026-10-03a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A211491-003PC2026-10-03a50c72e98297…

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 · 2 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 reactionsExact identifier
application applno (ANDA): 211491
application number: ANDA211491
Dapagliflozin and Metformin HydrochlorideDAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDESun Pharmaceutical Industries, Inc.bddc2d47-8d3d-4c2f-8e5c-7a1a0782219a2026-03-31Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211491
application number: ANDA211491

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
60240ORIG2019-10-04