Application 090615

Type
ANDA
Sponsor
WOCKHARDT

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 25MG TARTRATENoNo
002METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 50MG TARTRATENoNo
003METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATENoNo
004METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 200MG TARTRATENoNo

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

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
A090615-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22
A090615-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22
A090615-003METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22
A090615-004METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A090615-001AB
A090615-002AB
A090615-003AB
A090615-004AB

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 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2284e616aacf4f…
2026-09-14 22:38:342026-08A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2284e616aacf4f…
2026-09-14 22:38:342026-08A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2284e616aacf4f…
2026-09-14 22:38:342026-08A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2284e616aacf4f…
2026-08-18 06:07:402026-07A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22caaa826d4ba7…
2026-08-18 06:07:402026-07A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-003METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-004METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2010-07-225bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 172 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A090615-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A090615-002AB184e616aacf4f…
2026-09-14 22:38:342026-08A090615-003AB184e616aacf4f…
2026-09-14 22:38:342026-08A090615-004AB184e616aacf4f…
2026-08-18 06:07:402026-07A090615-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090615-002AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090615-003AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A090615-004AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090615-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090615-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090615-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A090615-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090615-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090615-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090615-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090615-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A090615-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090615-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090615-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090615-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090615-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090615-004AB15bbf6a4d5a75…

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 5 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions114346a1-ce49-49d2-9674-2fa6a49749c32025-09-05Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions46c288aa-a55c-4207-9a6e-ceef3c2f60ff2025-09-05Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEAvPAK71b27b55-44aa-113d-e053-2995a90a1cf72025-08-26Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATECardinal Health 107, LLC184db12c-0642-4741-a997-cd0b2a5ce3372025-08-20Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATECardinal Health 107, LLCe2f8dd23-600f-460e-aced-4e13504628f12025-08-20Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATECardinal Health 107, LLC1ab032d6-db68-4108-85d1-56e828d0dc012025-08-20Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATECardinal Health 107, LLCf6689572-d53d-49eb-a932-85056612a3552025-08-20Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEMajor Pharmaceuticals459fe5ce-14d1-4901-956a-b5597ea9016c2025-08-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Limited71c1d33e-be6f-6d59-b715-45075445891a2025-07-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEQuallent Pharmaceuticals Health LLC250c2428-c8b0-5156-697a-60cb8a45713c2025-07-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEQuallent Pharmaceuticals Health LLCe147a897-4a23-1e1a-73cd-f2e6c9a7280d2025-07-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATENorthstar Rx LLCad097646-cc77-8d67-5974-cc00060409f22025-07-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATENorthstar Rx LLCd887be8a-e6c2-5129-edbd-d7b2c0283dca2025-07-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEA-S Medication Solutions5223b690-0ccd-4ec4-b83b-22ce392713b22025-07-03Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEA-S Medication Solutions4da96d34-ae8e-4c63-8ba0-bbeefdc205162025-07-03Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.35304060-0965-488d-9e6e-bd1217286ea12025-06-27Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEBryant Ranch Prepack75f6c399-7a55-49a2-a8bb-dec534e375482025-06-04Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSAscend Laboratories, LLC58441cd3-6043-4bb8-adab-1b32a203bfb22025-05-29Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionscbc32a80-717b-4cf2-b76a-6d03a37204192025-05-21Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEPreferred Pharmaceuticals Inc.21e18c1c-fabb-44a4-a33a-b02a47967d732025-04-30Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE

Reported adverse events (FAERS/openFDA)#

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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0615-6589METOPROLOL SUCCINATEMETOPROLOL SUCCINATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6597METOPROLOL SUCCINATEMETOPROLOL SUCCINATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-6598METOPROLOL SUCCINATEMETOPROLOL SUCCINATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
0615-7530METOPROLOL SUCCINATEMETOPROLOL SUCCINATENCS HealthCare of KY, Inc dba Vangard LabsANDACurrent
50436-7053Metoprolol SuccinateMetoprolol SuccinateUnit Dose ServicesANDACurrent
50436-7056Metoprolol SuccinateMetoprolol SuccinateUnit Dose ServicesANDACurrent
55648-734Metoprolol SuccinateMetoprolol SuccinateWockhardt LimitedANDACurrent
55648-735Metoprolol SuccinateMetoprolol SuccinateWockhardt LimitedANDACurrent
55648-736Metoprolol SuccinateMetoprolol SuccinateWockhardt LimitedANDACurrent
55648-737Metoprolol SuccinateMetoprolol SuccinateWockhardt LimitedANDACurrent
64679-734Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-734Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-735Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-735Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-736Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-736Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-737Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-737Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
43240ORIG2012-02-14