Application 203028

Type
ANDA
Sponsor
PHARMADAX INC

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

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203028-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31
A203028-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A203028-001AB
A203028-002AB

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 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3184e616aacf4f…
2026-09-14 22:38:342026-08A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3184e616aacf4f…
2026-08-18 06:07:402026-07A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31caaa826d4ba7…
2026-08-18 06:07:402026-07A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-314b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203028-001METOPROLOL SUCCINATEEQ 25MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203028-002METOPROLOL SUCCINATEEQ 50MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203028-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203028-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A203028-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203028-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203028-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203028-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203028-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203028-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203028-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203028-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203028-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203028-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203028-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203028-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203028-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203028-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203028-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203028-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203028-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203028-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203028-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203028-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203028-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203028-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203028-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203028-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203028-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203028-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203028-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203028-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203028-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203028-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203028-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203028-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203028-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203028-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203028-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203028-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203028-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203028-002AB1bb7c543d1eb4…

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 7 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions712e8b44-c659-4344-8550-ce43f94223002024-12-03Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
metoprolol succinateMETOPROLOL SUCCINATEActavis Pharma, Inc.b798601e-a369-4c8b-8235-08900e1b751d2024-12-01Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepackef628c06-756b-4f17-9960-439eaf7154442024-11-07Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol succinateMETOPROLOL SUCCINATENCS HealthCare of KY, LLC dba Vangard Labs53613463-d5b6-41e7-aa43-1b75633c61fd2024-09-24Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepacka644027d-6f66-4467-a9ac-2ebcf28397442024-08-27Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack2f7730bb-74ac-488b-965a-7dcdaac9d6e42024-08-20Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
metoprolol succinateMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.ca8dbdc1-0137-8a89-e053-2995a90a66fd2024-07-30Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.a849d489-8f8c-18e6-e053-2995a90a37702024-07-17Boxed warning, Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack6103540c-93b5-46e8-9ef3-5059fa0335ab2024-07-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEGranules Pharmaceuticals Inc.ff180ca2-7490-a571-e053-6394a90a97b12024-07-05Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionsaa1c7d31-78be-465f-9564-03685a58add82024-06-18Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionsf09d07f1-e0d1-444d-8e8a-f340f7377c8d2024-06-18Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATESlate Run Pharmaceuticals, LLCc00f99e2-7a88-6f9b-e053-2995a90a6ace2024-05-17Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
metoprolol succinateMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.d96a039f-c3e5-4749-e053-2995a90abcb22024-03-25Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions342846fb-d42f-4d96-a8b5-7bcf1dcaef2f2024-03-18Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutions836c4a24-42f6-451a-8911-23444e01e5e82024-03-18Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATECamber Pharmaceuticals, Inc.74a28333-53c1-493e-b6ad-2192fdc353912024-03-12Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATE ERMETOPROLOL SUCCINATEDirect_Rx7ea78d2a-aa9f-38d4-e053-2991aa0a07fe2024-01-10Boxed warning, Warnings, Adverse reactionsName fallback
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEDirect_Rx90a69a79-5517-0ccf-e053-2995a90a441f2024-01-09Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEA-S Medication Solutions5fccf8de-d0f7-4ad1-b53f-6c2b1025ba1b2023-12-14Warnings, 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 · 8 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60050-001Metoprolol SuccinateMetoprolol SuccinatePharmadax Inc.ANDACurrent
60050-002Metoprolol SuccinateMetoprolol SuccinatePharmadax Inc.ANDACurrent
64679-846Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-846Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-847Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-847Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
75834-290Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-291Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent