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 | Bryant Ranch Prepack | 42bb324d-8b1e-45db-b15e-3845eec83c38 | 2023-12-05 | Boxed warning, Warnings, Adverse reactions | Metoprolol succinate METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | Bryant Ranch Prepack | 26d22b60-4414-40e3-9157-5e67340a0106 | 2023-10-27 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Proficient Rx LP | 502653e6-1971-4abf-9b21-ba0a9957672b | 2023-10-01 | Warnings, Adverse reactions | Metoprolol Succinate METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | A-S Medication Solutions | a022ac8a-15dc-4606-95c2-d7de176a3561 | 2023-09-17 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | A-S Medication Solutions | c8c02764-ef49-4ee4-a3b1-9660cf0e582d | 2023-09-17 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | A-S Medication Solutions | b89de581-2a6f-4dc2-ae82-ae6a6a209966 | 2023-09-17 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | e780699f-d795-44ce-9828-a0caa6283fb3 | 2023-09-11 | Warnings, Adverse reactions | Metoprolol succinate METOPROLOL SUCCINATE |
| METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | A-S Medication Solutions | 91e401fe-ec92-494e-9966-35c280f23efa | 2023-09-05 | Warnings, Adverse reactions | METOPROLOL SUCCINATE METOPROLOL SUCCINATE |
| METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | A-S Medication Solutions | 820a962a-5b15-4beb-bd78-e1ac10cb2e0e | 2023-09-05 | Warnings, Adverse reactions | METOPROLOL SUCCINATE METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | A-S Medication Solutions | 907a35b0-3e0b-40bb-93fd-62b137454b62 | 2023-08-24 | Warnings, Adverse reactions | Metoprolol Succinate |
| METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | BluePoint Laboratories | 6a4f2446-a9e4-479a-87bd-2d5539dcded9 | 2023-08-08 | Warnings, Adverse reactions | METOPROLOL SUCCINATE METOPROLOL SUCCINATE |
| METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | Bryant Ranch Prepack | 5bf27a6c-ea3f-425e-9cfc-a5a308e2af1c | 2023-07-11 | Warnings, Adverse reactions | METOPROLOL SUCCINATE METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE ER TABLETS | A-S Medication Solutions | 8bdc7ee4-bf10-4ee7-aa82-3a2d20e4bc2f | 2023-06-15 | Warnings, Adverse reactions | Metoprolol Succinate |
| Metoprolol Succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | 5ee51a50-0187-4156-84fa-95e68f5c353b | 2023-05-19 | Warnings, Adverse reactions | Metoprolol Succinate METOPROLOL SUCCINATE |
| metoprolol succinate | METOPROLOL SUCCINATE | Proficient Rx LP | 57e33bcf-b380-44bb-b96e-3a637af6233a | 2023-05-01 | Warnings, Adverse reactions | metoprolol succinate METOPROLOL SUCCINATE |
| metoprolol succinate | METOPROLOL SUCCINATE | Proficient Rx LP | 64c65611-d5c9-4802-9edd-32c7c67ce6f4 | 2023-05-01 | Boxed warning, Warnings, Adverse reactions | metoprolol succinate METOPROLOL SUCCINATE |
| Metoprolol Succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | e91e8ee2-4a54-4932-9d8b-5831121377a4 | 2023-04-30 | Warnings, Adverse reactions | Metoprolol Succinate METOPROLOL SUCCINATE |
| KAPSPARGO | METOPROLOL SUCCINATE | Sun Pharmaceutical Industries, Inc. | 9cfa55b4-15c6-40f7-b6e5-41096ee51bfc | 2023-04-12 | Warnings, Adverse reactions | METOPROLOL SUCCINATE |
| METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | Cipla USA Inc. | 3a4966a2-2728-4c99-999f-576b3e2df90c | 2023-04-07 | Warnings, Adverse reactions | METOPROLOL SUCCINATE METOPROLOL SUCCINATE |
| Metoprolol succinate | METOPROLOL SUCCINATE | Dr. Reddy's Laboratories Limited | 90594d68-87f2-5f75-2d8a-1629f88ba8a9 | 2023-03-20 | 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 |