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 8 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack42bb324d-8b1e-45db-b15e-3845eec83c382023-12-05Boxed warning, Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSBryant Ranch Prepack26d22b60-4414-40e3-9157-5e67340a01062023-10-27Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol SuccinateMETOPROLOL SUCCINATEProficient Rx LP502653e6-1971-4abf-9b21-ba0a9957672b2023-10-01Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSA-S Medication Solutionsa022ac8a-15dc-4606-95c2-d7de176a35612023-09-17Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSA-S Medication Solutionsc8c02764-ef49-4ee4-a3b1-9660cf0e582d2023-09-17Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSA-S Medication Solutionsb89de581-2a6f-4dc2-ae82-ae6a6a2099662023-09-17Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol succinateMETOPROLOL SUCCINATEA-S Medication Solutionse780699f-d795-44ce-9828-a0caa6283fb32023-09-11Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEA-S Medication Solutions91e401fe-ec92-494e-9966-35c280f23efa2023-09-05Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEA-S Medication Solutions820a962a-5b15-4beb-bd78-e1ac10cb2e0e2023-09-05Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSA-S Medication Solutions907a35b0-3e0b-40bb-93fd-62b137454b622023-08-24Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEBluePoint Laboratories6a4f2446-a9e4-479a-87bd-2d5539dcded92023-08-08Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATEBryant Ranch Prepack5bf27a6c-ea3f-425e-9cfc-a5a308e2af1c2023-07-11Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATE ER TABLETSA-S Medication Solutions8bdc7ee4-bf10-4ee7-aa82-3a2d20e4bc2f2023-06-15Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
Metoprolol SuccinateMETOPROLOL SUCCINATEA-S Medication Solutions5ee51a50-0187-4156-84fa-95e68f5c353b2023-05-19Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP57e33bcf-b380-44bb-b96e-3a637af6233a2023-05-01Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
metoprolol succinateMETOPROLOL SUCCINATEProficient Rx LP64c65611-d5c9-4802-9edd-32c7c67ce6f42023-05-01Boxed warning, Warnings, Adverse reactionsName fallback
brand name: metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEA-S Medication Solutionse91e8ee2-4a54-4932-9d8b-5831121377a42023-04-30Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
KAPSPARGOMETOPROLOL SUCCINATESun Pharmaceutical Industries, Inc.9cfa55b4-15c6-40f7-b6e5-41096ee51bfc2023-04-12Warnings, Adverse reactionsName fallback
generic name: METOPROLOL SUCCINATE
METOPROLOL SUCCINATEMETOPROLOL SUCCINATECipla USA Inc.3a4966a2-2728-4c99-999f-576b3e2df90c2023-04-07Warnings, Adverse reactionsName fallback
brand name: METOPROLOL SUCCINATE
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Limited90594d68-87f2-5f75-2d8a-1629f88ba8a92023-03-20Warnings, 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