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 3 of 9 · 173 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol succinateMETOPROLOL SUCCINATEAphena Pharma Solutions - Tennessee, LLC51b630c7-6c03-7876-e063-6294a90acb302026-05-13Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATERedpharm Drug301ec2ea-84cb-ad89-e063-6294a90af49d2026-04-21Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEIngenus Pharmaceuticals, LLC9dcd1fdf-a651-48d4-8033-e5749d5f56502026-04-15Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEST. MARY'S MEDICAL PARK PHARMACY4f59e872-8dab-8c35-e063-6294a90a15d52026-04-13Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATECardinal Health 107, LLC028049cd-d233-49f9-87fa-ec91e433a49f2026-04-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEProficient Rx LP9bd9ff03-7c11-41c9-9054-126313d105062026-04-01Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEZhejiang Jutai Pharamceutical Co., Ltd4df90eca-70e3-5c7c-e063-6294a90adc412026-03-26Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEMajor Pharmaceuticals14ab9921-4651-4abc-92dc-aab1719b6bb02026-03-16Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
TOPROL XLMETOPROLOL SUCCINATEMelinta Therapeutics, LLC496ddfaa-7c9c-4888-b747-a210249b367a2026-03-03Warnings, Adverse reactionsName fallback
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATENuCare Pharmaceuticals, Inc.4b1cfb2f-2345-af53-e063-6294a90a4ff02026-02-18Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEBluePoint Laboratoriesd92dc643-37b1-4d1e-8fc0-cfb27c3e27022026-02-12Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATENuCare Pharmaceuticals,Inc.4a900d2c-12d1-6bfa-e063-6294a90af0092026-02-11Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEBryant Ranch Prepack860e0ee0-b24f-4eff-b196-b9b03b37d3d52026-02-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATECoupler LLC48ec9246-f887-2ed4-e063-6394a90ac9522026-01-21Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Inc24c87741-ee0a-738e-2c5a-5ce80ca2f48b2026-01-13Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEDr. Reddy's Laboratories Inc5b7095c8-f8b7-adc7-9052-92325da33a022026-01-13Warnings, Adverse reactionsName fallback
brand name: Metoprolol succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATEPD-Rx Pharmaceuticals, Inc.ff3eaf6a-5697-4ad9-98c4-86925e6da2572026-01-12Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATENorthwind Health Company, LLC471f154c-197f-31df-e063-6394a90ae73e2026-01-12Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol SuccinateMETOPROLOL SUCCINATENuCare Pharmaceuticals, Inc.47f96afd-1483-66d5-e063-6294a90a201f2026-01-09Warnings, Adverse reactionsName fallback
brand name: Metoprolol Succinate
generic name: METOPROLOL SUCCINATE
Metoprolol succinateMETOPROLOL SUCCINATEREMEDYREPACK INC.874a38ba-667e-47b6-a918-a972c0e3ed592026-01-08Warnings, 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