Application 077298
- Type
- ANDA
- Sponsor
- ACTAVIS LABS FL INC
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG TARTRATE | No | No |
| 002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 200MG TARTRATE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A077298-001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | ||
| A077298-002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2010-04-15 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A077298-001 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-04-15 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A077298-002 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2010-04-15 | 74a2ff9319b5… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A077298-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A077298-002 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A077298-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A077298-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A077298-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A077298-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A077298-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A077298-002 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Metoprolol succinate | METOPROLOL SUCCINATE | NuCare Pharmaceutcals, Inc. | 32341a31-a2db-cf13-e063-6394a90aad89 | 2025-04-07 | Warnings, Adverse reactions | Metoprolol succinate METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | e602c70f-9ea3-480f-a7df-15f23c6b3307 | 2025-04-01 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 28ca1918-c220-41b3-9e58-a0a023f775d0 | 2025-04-01 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 8ed15c20-23a2-40ba-95e8-2689d182a52f | 2025-04-01 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 01908d20-0e16-4410-bd27-1b6df162ede4 | 2025-04-01 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Cranbury Pharmaceuticals, LLC | 8b8cae90-e02a-4a99-81ff-37629c9a4243 | 2025-03-30 | Warnings, Adverse reactions | Metoprolol Succinate METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 89e642f6-5f8c-4352-8da6-7b74ed4ff23c | 2025-03-28 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 8d812b11-c9ec-470e-a108-70d86403e473 | 2025-03-28 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 2ef668c8-7279-4f61-b6af-9c4ccb3b90d0 | 2025-03-28 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | dbb4cadc-5af0-4ff5-ab6c-8bf1b68b700c | 2025-03-28 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | afa6c1f5-0c8e-496f-930a-1ade1f69646b | 2025-03-28 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 123f2051-4bff-4621-aaba-65f54f4e7784 | 2025-03-28 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | d1bbf535-8b02-4d99-bb4d-2e87454c1d61 | 2025-03-27 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 52496331-174e-4ae3-9763-6b9a4072befd | 2025-03-27 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE | PD-Rx Pharmaceuticals, Inc. | 4d8cdd8b-3896-4cd0-9570-a6f4e1d340d7 | 2025-03-18 | Warnings, Adverse reactions | Metoprolol Succinate METOPROLOL SUCCINATE |
| Metoprolol succinate | METOPROLOL SUCCINATE | NCS HealthCare of KY, LLC dba Vangard Labs | c4fb991c-025c-4a1d-9766-4b62ad70b5fe | 2025-02-19 | Warnings, Adverse reactions | Metoprolol succinate METOPROLOL SUCCINATE |
| metoprolol succinate | METOPROLOL SUCCINATE | Proficient Rx LP | e29d6ea1-1374-4572-ad7e-b0c2ea48ca04 | 2025-02-01 | Warnings, Adverse reactions | metoprolol succinate METOPROLOL SUCCINATE |
| Metoprolol succinate | METOPROLOL SUCCINATE | Epic Pharma, LLC | 2c70177a-615b-4ed7-a58f-a298212e8fae | 2025-01-24 | Warnings, Adverse reactions | Metoprolol succinate METOPROLOL SUCCINATE |
| metoprolol succinate | METOPROLOL SUCCINATE | Redpharm Drug | 0b25ce23-6d78-bc88-e063-6294a90abb78 | 2025-01-23 | Warnings, Adverse reactions | metoprolol succinate METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Oryza Pharmaceuticals, Inc | 6cfe96df-bd75-432d-b2c2-e26143ca36dd | 2025-01-09 | Warnings, Adverse reactions | Metoprolol Succinate METOPROLOL SUCCINATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-972 | Metoprolol Succinate | Metoprolol Succinate | Rebel Distributors Corp | ANDA | Current |
| 43353-795 | Metoprolol Succinate | Metoprolol Succinate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 50090-3383 | Metoprolol Succinate | Metoprolol Succinate | A-S Medication Solutions | ANDA | Current |
| 50090-3383 | Metoprolol Succinate | Metoprolol Succinate | A-S Medication Solutions | ANDA | Current |
| 60429-141 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-141 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-141 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-142 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-142 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-142 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 62037-832 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-832 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-832 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-832 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-832 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-833 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-833 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-833 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-833 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 63187-547 | Metoprolol Succinate | Metoprolol Succinate | Proficient Rx LP | ANDA | Current |
| 63187-547 | Metoprolol Succinate | Metoprolol Succinate | Proficient Rx LP | ANDA | Current |
| 63629-4387 | Metoprolol Succinate ER | Metoprolol Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63629-4387 | Metoprolol Succinate ER | Metoprolol Succinate | Bryant Ranch Prepack | ANDA | Current |
| 63739-454 | Metoprolol Succinate | Metoprolol Succinate | McKesson Corporation dba SKY Packaging | ANDA | Current |
| 63739-454 | Metoprolol Succinate | Metoprolol Succinate | McKesson Corporation | ANDA | Current |
| 68071-1923 | Metoprolol Succinate | Metoprolol Succinate | NuCare Pharmaceuticals, Inc. | ANDA | Current |
| 68788-6785 | Metoprolol Succinate | Metoprolol Succinate | Preferred Pharmaceuticals, Inc. | ANDA | Current |
| 70518-0611 | Metoprolol Succinate | Metoprolol Succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0611 | Metoprolol Succinate | Metoprolol Succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0611 | Metoprolol Succinate | Metoprolol Succinate | REMEDYREPACK INC. | ANDA | Current |