Application 076862
- 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 50MG TARTRATE | No | No |
| 002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG TARTRATE | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A076862-001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | |
| A076862-002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A076862-001 | AB |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 8072bd15b7f6… | |
| 2024-05-31 18:47 UTC | 2024-05 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 5c6f7cd8ea54… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 5d02ea3f76ae… | |
| 2022-04-08 23:34 UTC | 2022-04 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 4b0b4de00fa7… | |
| 2022-04-04 05:41 UTC | 2022-04 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A076862-001 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2009-08-03 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | A076862-002 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | 2009-08-03 | 782e0a99824c… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A076862-001 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A076862-001 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A076862-001 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A076862-001 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A076862-001 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A076862-001 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A076862-001 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A076862-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A076862-001 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A076862-001 | AB | 1 | d06236e962d9… |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A076862-001 | AB | 1 | 79d66fd596c7… |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A076862-001 | AB | 1 | 301d65b070ca… |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A076862-001 | AB | 1 | 1e350fbaab3a… |
| 2024-05-31 18:47 UTC | 2024-05 | A076862-001 | AB | 1 | 8072bd15b7f6… |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A076862-001 | AB | 1 | 5c6f7cd8ea54… |
| 2022-04-08 23:34 UTC | 2022-04 | A076862-001 | AB | 1 | 5d02ea3f76ae… |
| 2022-04-04 05:41 UTC | 2022-04 | A076862-001 | AB | 1 | 4b0b4de00fa7… |
| 2019-12-13 00:20 UTC | 2019-12 | A076862-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-13 00:20 UTC | 2019-12 | A076862-002 | AB | 1 | 74a2ff9319b5… |
| 2022-03-09 01:35 UTC | 2022-03 | A076862-001 | AB | 1 | bb7c543d1eb4… |
| 2021-12-28 21:50 UTC | 2021-12 | A076862-001 | AB | 1 | 782e0a99824c… |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A076862-001 | AB | 1 | 87673890dc5c… |
| 2021-03-12 10:30 UTC | 2021-03 | A076862-001 | AB | 1 | 5aa47cf7b7d7… |
| 2020-12-22 03:56 UTC | 2020-12 | A076862-001 | AB | 1 | 8869cabd3fbd… |
| 2020-11-12 02:37 UTC | 2020-11 | A076862-001 | AB | 1 | c0c555d07b60… |
| 2019-12-14 00:12 UTC | 2019-12 | A076862-001 | AB | 1 | 3f01610625f2… |
| 2019-12-14 00:12 UTC | 2019-12 | A076862-002 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A076862-001 | AB | 1 | b00525d2431f… |
| 2019-09-15 20:21 UTC | 2019-09 | A076862-002 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A076862-001 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | A076862-002 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A076862-001 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | A076862-001 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | A076862-001 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A076862-001 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A076862-001 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A076862-001 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A076862-001 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | A076862-001 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | A076862-001 | AB | 1 | 3bdfa0b2c4d7… |
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.
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 21695-950 | Metoprolol Succinate | Metoprolol Succinate | Rebel Distributors Corp | ANDA | Current |
| 43063-663 | Metoprolol Succinate | Metoprolol Succinate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-663 | Metoprolol Succinate | Metoprolol Succinate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-663 | Metoprolol Succinate | Metoprolol Succinate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43063-663 | Metoprolol Succinate | Metoprolol Succinate | PD-Rx Pharmaceuticals, Inc. | ANDA | Current |
| 43353-583 | Metoprolol Succinate | Metoprolol Succinate | Aphena Pharma Solutions - Tennessee, LLC | ANDA | Current |
| 51655-580 | Metoprolol Succinate | Metoprolol Succinate | Northwind Pharmaceuticals | ANDA | Current |
| 55700-376 | Metoprolol Succinate | Metoprolol Succinate | Lake Erie Medical DBA Quality Care Products LLC | ANDA | Current |
| 60429-139 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-140 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 60429-140 | Metoprolol Succinate | Metoprolol Succinate | Golden State Medical Supply, Inc. | ANDA | Current |
| 62037-830 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-830 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-830 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-831 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-831 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-831 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-831 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 62037-831 | Metoprolol Succinate | Metoprolol Succinate | Actavis Pharma, Inc. | ANDA | Current |
| 63187-546 | Metoprolol Succinate | Metoprolol Succinate | Proficient Rx LP | ANDA | Current |
| 63187-546 | Metoprolol Succinate | Metoprolol Succinate | Proficient Rx LP | ANDA | Current |
| 67296-1149 | Metoprolol Succinate | Metoprolol Succinate | RedPharm Drug, Inc. | ANDA | Current |
| 67296-1149 | Metoprolol Succinate | Metoprolol Succinate | RedPharm Drug, Inc. | ANDA | Current |
| 68071-4074 | Metoprolol Succinate | Metoprolol Succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68258-6019 | Metoprolol Succinate | Metoprolol Succinate | Dispensing Solutions, Inc. | ANDA | Current |
| 70518-0655 | Metoprolol Succinate | Metoprolol Succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-0655 | Metoprolol Succinate | Metoprolol Succinate | REMEDYREPACK INC. | ANDA | Current |
| 71335-0523 | Metoprolol Succinate | Metoprolol Succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0523 | Metoprolol Succinate | Metoprolol Succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-0948 | Metoprolol Succinate | Metoprolol Succinate | Bryant Ranch Prepack | ANDA | Current |