Application 074141

Type
ANDA
Sponsor
HERITAGE PHARMA

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL50MGNoNo
002METOPROLOL TARTRATEMETOPROLOL TARTRATETABLET;ORAL100MGNoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A074141-001METOPROLOL TARTRATEMETOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31
A074141-002METOPROLOL TARTRATEMETOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31caaa826d4ba7…
2026-08-18 06:07:402026-07A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31d06236e962d9…
2024-10-29 15:01 UTC2024-10A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074141-001METOPROLOL TARTRATE50MGTABLET / ORALAB1995-01-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074141-002METOPROLOL TARTRATE100MGTABLET / ORALAB1995-01-3174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074141-001METOPROLOL TARTRATE50MGTABLET / ORAL1995-01-31bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A074141-002METOPROLOL TARTRATE100MGTABLET / ORAL1995-01-31bb7c543d1eb4…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A074141-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A074141-002AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A074141-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A074141-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A074141-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A074141-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A074141-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A074141-002AB1ea99ee380514…

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 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Metoprolol TartrateMETOPROLOL TARTRATEPD-Rx Pharmaceuticals, Inc.cbcec1e7-7eac-456e-a253-aaf6761b48832026-08-11Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.c9ccdbc0-0e4e-40c4-aacf-de60deda9fd52026-08-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.3a236293-35c1-4083-9805-ab40df5350832026-08-06Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOLREMEDYREPACK INC.58d493d3-b69c-422a-b6a8-0f8fa1e555452026-08-04Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOL TARTRATEREMEDYREPACK INC.58239cf1-53b4-4ef7-e063-6394a90a65bd2026-08-03Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATECardinal Health 107, LLC6399f2c3-7799-4f8b-b8b7-8d2137b1f8522026-07-28Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEREMEDYREPACK INC.028b6e4a-1597-4d21-89d0-0bbbad21efa82026-07-27Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOLBryant Ranch Prepack00940cc5-d2eb-4841-9138-de97d7b1c6742026-07-27Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOLNorthwind Health Company, LLC471ccbfe-96dd-7ab9-e063-6394a90a5bd62026-07-21Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOL TARTRATEAphena Pharma Solutions - Tennessee, LLC5476c4fc-ab09-ee1a-e063-6394a90a7a1b2026-07-13Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATECardinal Health 107, LLC0ccb9d3c-3f9a-486d-9b27-dc6f3ef6f4ed2026-07-10Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATESafecor Health, LLC63d45147-9b37-40e2-9619-cd1a3e77ff312026-07-10Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEBryant Ranch Prepacka590edb1-3310-49e3-b3d1-dbbb3f81f1c12026-07-10Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEAmerican Health Packaging0a3ccfd4-8b65-4c7e-b0ba-27ff40d5b5e82026-07-02Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOL TARTRATESt. Mary's Medical Park Pharmacy3bc7d371-6057-a9dc-e063-6394a90a6a9c2026-06-26Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals Inc.5fd16fbd-be05-49aa-86a9-0f775c1b5a372026-06-26Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals Inc.9af11192-61fa-44b8-86eb-3a5e68ec17472026-06-26Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATEPreferred Pharmaceuticals, Inc.b4d1e5ba-f1a8-4c77-bd65-db8e9342370b2026-06-25Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE
METOPROLOL TARTRATEMETOPROLOLREMEDYREPACK INC.e1c99d45-8f42-46b1-b770-14d0eb2b300a2026-06-24Warnings, Adverse reactionsName fallback
brand name: METOPROLOL TARTRATE
Metoprolol TartrateMETOPROLOL TARTRATESt. Mary's Medical Park Pharmacye3de73ee-bcc7-ba40-e053-2a95a90a8f8f2026-06-24Warnings, Adverse reactionsName fallback
brand name: Metoprolol Tartrate
generic name: METOPROLOL TARTRATE

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 3 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
10544-263Metoprolol TartrateMetoprolol TartrateBlenheim Pharmacal, Inc.ANDACurrent
48433-312Metoprolol TartrateMetoprolol TartrateSafecor Health, LLCANDACurrent
66116-810Metoprolol TartrateMetoprolol TartrateMedVantx, Inc.ANDACurrent