Application 210428

Type
NDA
Sponsor
SPIL

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 25MG TARTRATEYesNo
002KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 50MG TARTRATEYesNo
003KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 100MG TARTRATEYesNo
004KAPSPARGO SPRINKLEMETOPROLOL SUCCINATECAPSULE, EXTENDED RELEASE;ORALEQ 200MG TARTRATEYesYes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N210428-001KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26
N210428-002KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26
N210428-003KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26
N210428-004KAPSPARGO SPRINKLEMETOPROLOL SUCCINATEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26

Orange Book patents#

Current patent rows page 1 of 1 · 8 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N210428-00195046552035-07-09Drug product2018-03-14
N210428-00197005302035-07-09Drug product2018-03-14
N210428-00295046552035-07-09Drug product2018-03-14
N210428-00297005302035-07-09Drug product2018-03-14
N210428-00395046552035-07-09Drug product2018-03-14
N210428-00397005302035-07-09Drug product2018-03-14
N210428-00495046552035-07-09Drug product2018-03-14
N210428-00497005302035-07-09Drug product2018-03-14

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.

Product history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-266a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-2603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-262680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-265bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N210428-001KAPSPARGO SPRINKLEEQ 25MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N210428-002KAPSPARGO SPRINKLEEQ 50MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N210428-003KAPSPARGO SPRINKLEEQ 100MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD2018-01-26d06236e962d9…
2024-10-29 15:01 UTC2024-10N210428-004KAPSPARGO SPRINKLEEQ 200MG TARTRATECAPSULE, EXTENDED RELEASE / ORALRLD, RS2018-01-26d06236e962d9…

Observed Orange Book patent history#

Patent history page 1 of 9 · 328 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N210428-00195046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00197005302035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00295046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00297005302035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00395046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00397005302035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00495046552035-07-09Drug product2018-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02N210428-00497005302035-07-09Drug product2018-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00195046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00197005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00295046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00297005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00395046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00397005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00495046552035-07-09Drug product2018-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N210428-00497005302035-07-09Drug product2018-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N210428-00195046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00197005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00295046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00297005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00395046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00397005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00495046552035-07-09Drug product2018-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08N210428-00497005302035-07-09Drug product2018-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00195046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00197005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00295046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00297005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00395046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00397005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00495046552035-07-09Drug product2018-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N210428-00497005302035-07-09Drug product2018-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00195046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00197005302035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00295046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00297005302035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00395046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00397005302035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00495046552035-07-09Drug product2018-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N210428-00497005302035-07-09Drug product2018-03-14b8a1b40f171c…

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
KAPSPARGOMETOPROLOL SUCCINATESun Pharmaceutical Industries, Inc.9cfa55b4-15c6-40f7-b6e5-41096ee51bfc2023-04-12Warnings, Adverse reactionsExact identifier
application applno (NDA): 210428
application number: NDA210428
ndc (product): 10631-009
ndc (product): 10631-010
ndc (product): 10631-011
ndc (product): 10631-008
Metoprolol SuccinateMETOPROLOL SUCCINATESun Pharmaceutical Industries Inc.90aa06a3-100f-4466-b950-506303707b012018-02-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 210428
application number: NDA210428
ndc (product): 63304-008
ndc (product): 63304-011
ndc (product): 63304-009
ndc (product): 63304-010

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10631-008KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-008KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-009KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-009KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-010KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-010KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-011KAPSPARGOMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
10631-011KapspargoMetoprolol SuccinateSun Pharmaceutical Industries, Inc.NDACurrent
63304-008Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent
63304-009Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent
63304-010Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent
63304-011Metoprolol SuccinateMetoprolol SuccinateSun Pharmaceutical Industries Inc.NDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
74010SUPPL 2023-04-17
74004SUPPL 2023-04-17
55870ORIG2018-10-11
54245SUPPL2018-05-17
52132ORIG2018-01-30
52082ORIG2018-01-30
63172ORIG1900-01-01
63171ORIG1900-01-01