Application 203699

Type
ANDA
Sponsor
PHARMADAX INC

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL SUCCINATEMETOPROLOL SUCCINATETABLET, EXTENDED RELEASE;ORALEQ 100MG TARTRATENoNo
002METOPROLOL 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A203699-001METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30
A203699-002METOPROLOL SUCCINATEMETOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203699-001AB
A203699-002AB

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 22:38:342026-08A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3084e616aacf4f…
2026-09-14 22:38:342026-08A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3084e616aacf4f…
2026-08-18 06:07:402026-07A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30caaa826d4ba7…
2026-08-18 06:07:402026-07A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3031067a03dcf5…
2025-08-23 18:47 UTC2025-08A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-306a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-306a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-302680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-302680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d06236e962d9…
2024-10-29 15:01 UTC2024-10A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-3079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-301e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-301e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-308072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-308072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-305d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-304b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-304b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203699-001METOPROLOL SUCCINATEEQ 100MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203699-002METOPROLOL SUCCINATEEQ 200MG TARTRATETABLET, EXTENDED RELEASE / ORALAB2020-03-30bb7c543d1eb4…

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 22:38:342026-08A203699-001AB184e616aacf4f…
2026-09-14 22:38:342026-08A203699-002AB184e616aacf4f…
2026-08-18 06:07:402026-07A203699-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203699-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203699-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203699-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203699-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203699-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203699-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203699-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203699-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203699-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203699-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203699-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203699-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203699-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203699-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203699-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203699-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203699-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203699-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203699-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203699-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203699-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203699-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203699-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203699-002AB14b0b4de00fa7…
2022-03-09 01:35 UTC2022-03A203699-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203699-002AB1bb7c543d1eb4…

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 1 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol SuccinateMETOPROLOL SUCCINATEREMEDYREPACK INC.a46cbf09-20e3-4f0d-ab41-221f60fde0682026-09-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEGranules India Ltdc5431c8a-d92c-489e-b63b-4b9cc8f32a1a2026-09-04Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATERedpharm Drug5a65a60c-4c0d-e89b-e063-6394a90ac6892026-09-01Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEREMEDYREPACK INC.565bcddd-0720-484b-9316-d8fc0dc3ffab2026-08-31Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSREMEDYREPACK INC.76c69d7c-e90c-4f96-a45b-e9dad94442632026-08-31Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol SuccinateMETOPROLOL SUCCINATEREMEDYREPACK INC.c1d1726f-75c6-4c07-b5ff-565c4c4ca9042026-08-27Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATERedpharm Drug59ed0d9a-54c8-4c13-e063-6394a90a2aaa2026-08-26Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSREMEDYREPACK INC.28c22fb6-6cc9-4c41-b781-88b33b6c8cee2026-08-14Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol succinateMETOPROLOL SUCCINATERedpharm Drug58be9439-7943-3e41-e063-6394a90adddc2026-08-11Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepacka693bef9-cdfa-4012-ac87-873b9c5bf1cd2026-08-04Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEProficient Rx LPf2d7c4da-9df0-44d4-9db3-e47e9cce92542026-08-01Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBluePoint Laboratories6588d77c-090f-4722-9c91-437887d4624a2026-07-10Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol succinateMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLC52bdc5cc-973f-4af6-e063-6294a90aba222026-07-10Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATECoupler LLC55f1a53b-8ec1-8373-e063-6394a90a896c2026-07-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATECoupler LLC55f20cc3-d958-bd74-e063-6394a90a78502026-07-06Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATECoupler LLC55f47fad-ddc9-d9e6-e063-6394a90a48cf2026-07-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEPD-Rx Pharmaceuticals, Inc.98a39051-be63-4120-b247-50796656bd7c2026-07-02Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEAmerican Health Packaging74e3b4dc-eb30-4d7c-a558-cf58f64704962026-06-30Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepacka1997b48-8d66-437a-a253-ca996331b0c32026-06-29Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepackadc8234b-192a-4ca4-a949-3eabc11af5252026-06-29Warnings, 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 · 12 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
60050-003Metoprolol SuccinateMetoprolol SuccinatePharmadax Inc.ANDACurrent
60050-004Metoprolol SuccinateMetoprolol SuccinatePharmadax Inc.ANDACurrent
60760-563Metoprolol SuccinateMetoprolol SuccinateST. MARY'S MEDICAL PARK PHARMACYANDACurrent
64679-848Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-848Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-849Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
64679-849Metoprolol SuccinateMetoprolol SuccinateWockhardt USA LLC.ANDACurrent
70518-3545Metoprolol SuccinateMetoprolol SuccinateREMEDYREPACK INC.ANDACurrent
75834-292Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-292Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-293Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent
75834-293Metoprolol SuccinateMetoprolol SuccinateNivagen Pharmaceuticals, Inc.ANDACurrent