Application 203894
- Type
- ANDA
- Sponsor
- ZYDUS PHARMS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 25MG TARTRATE | No | No |
| 002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 50MG TARTRATE | No | No |
| 003 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | TABLET, EXTENDED RELEASE;ORAL | EQ 100MG TARTRATE | No | No |
| 004 | 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 |
|---|---|---|---|---|---|---|---|
| A203894-001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | |
| A203894-002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | |
| A203894-003 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | |
| A203894-004 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A203894-001 | AB |
| A203894-002 | AB |
| A203894-003 | AB |
| A203894-004 | 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 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2018-03-23 | d06236e962d9… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | A203894-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203894-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203894-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A203894-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A203894-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A203894-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A203894-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A203894-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A203894-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A203894-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A203894-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A203894-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A203894-004 | AB | 1 | d06236e962d9… |
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 | a1997b48-8d66-437a-a253-ca996331b0c3 | 2026-06-29 | Warnings, Adverse reactions | 203894 ANDA203894 71335-1878 |
| metoprolol succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | adc8234b-192a-4ca4-a949-3eabc11af525 | 2026-06-29 | Warnings, Adverse reactions | 203894 ANDA203894 71335-1875 |
| metoprolol succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | 9c33fc53-35d1-4b01-a805-ae737405db3f | 2026-06-29 | Warnings, Adverse reactions | 203894 ANDA203894 |
| metoprolol succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | 6da0e3dc-1b11-4975-b35c-5a6ca13cf990 | 2026-06-24 | Warnings, Adverse reactions | 203894 ANDA203894 63629-9413 |
| metoprolol succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | d58b56cc-1a3d-4147-afc2-12e8236c3766 | 2026-06-24 | Warnings, Adverse reactions | 203894 ANDA203894 71335-1951 |
| metoprolol succinate | METOPROLOL SUCCINATE | Northwind Health Company, LLC | 471bca3e-3401-6814-e063-6394a90a9cb1 | 2026-06-22 | Warnings, Adverse reactions | 203894 ANDA203894 |
| metoprolol succinate | METOPROLOL SUCCINATE | REMEDYREPACK INC. | c2eb2a77-761a-49c0-9eca-8eb57d8532d2 | 2026-06-15 | Warnings, Adverse reactions | 203894 ANDA203894 70518-3122 |
| metoprolol succinate | METOPROLOL SUCCINATE | St. Mary's Medical Park Pharmacy | 0a99ed82-2ee8-6f9c-e063-6394a90ac7ba | 2026-06-03 | Warnings, Adverse reactions | 203894 ANDA203894 |
| metoprolol succinate | METOPROLOL SUCCINATE | St Mary's Medical Park Pharmacy | cdb69427-0489-3751-e053-2995a90a3667 | 2026-06-01 | Warnings, Adverse reactions | 203894 ANDA203894 60760-634 |
| metoprolol succinate | METOPROLOL SUCCINATE | REMEDYREPACK INC. | ea67ed64-47df-4728-8e62-c5d7316a71aa | 2026-05-22 | Warnings, Adverse reactions | 203894 ANDA203894 70518-3143 |
| metoprolol succinate | METOPROLOL SUCCINATE | REMEDYREPACK INC. | eea82ccb-876b-4fe8-9270-dcea509029a5 | 2026-05-22 | Warnings, Adverse reactions | 203894 ANDA203894 70518-3164 |
| metoprolol succinate | METOPROLOL SUCCINATE | Zydus Pharmaceuticals (USA) Inc. | bd77ec6e-c58c-440b-81d6-8a462b2fdc9c | 2026-05-19 | Warnings, Adverse reactions | 203894 ANDA203894 68382-567 68382-566 68382-564 68382-565 |
| metoprolol succinate | METOPROLOL SUCCINATE | Zydus Lifesciences Limited | 1098f26d-8319-4dba-ad66-3df22db2b399 | 2026-05-19 | Warnings, Adverse reactions | 203894 ANDA203894 70771-1341 70771-1338 70771-1340 70771-1339 |
| metoprolol succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | cbc32a80-717b-4cf2-b76a-6d03a3720419 | 2025-05-21 | Warnings, Adverse reactions | 203894 ANDA203894 50090-5418 |
| metoprolol succinate | METOPROLOL SUCCINATE | Proficient Rx LP | e29d6ea1-1374-4572-ad7e-b0c2ea48ca04 | 2025-02-01 | Warnings, Adverse reactions | 203894 ANDA203894 |
| metoprolol succinate | METOPROLOL SUCCINATE | Redpharm Drug | 0b25ce23-6d78-bc88-e063-6294a90abb78 | 2025-01-23 | Warnings, Adverse reactions | 203894 ANDA203894 |
| metoprolol succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | 712e8b44-c659-4344-8550-ce43f9422300 | 2024-12-03 | Warnings, Adverse reactions | 203894 ANDA203894 50090-5411 |
| metoprolol succinate | METOPROLOL SUCCINATE | NuCare Pharmaceuticals,Inc. | ca8dbdc1-0137-8a89-e053-2995a90a66fd | 2024-07-30 | Boxed warning, Warnings, Adverse reactions | 203894 ANDA203894 68071-2522 |
| Metoprolol Succinate ER | METOPROLOL SUCCINATE ER | Direct_Rx | 15d5c223-af4e-e803-e063-6294a90af3d8 | 2024-04-11 | Warnings, Adverse reactions | 203894 ANDA203894 |
| metoprolol succinate | METOPROLOL SUCCINATE | NuCare Pharmaceuticals,Inc. | d96a039f-c3e5-4749-e053-2995a90abcb2 | 2024-03-25 | Warnings, Adverse reactions | 203894 ANDA203894 68071-2651 |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 16714-852 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-852 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-852 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-852 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-853 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-853 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-853 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-853 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-854 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-854 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-854 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-854 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-855 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-855 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-855 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 16714-855 | metoprolol succinate | metoprolol succinate | Northstar Rx LLC | ANDA | Current |
| 50090-5392 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5393 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5411 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5411 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5412 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5418 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5418 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5418 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 50090-5419 | metoprolol succinate | metoprolol succinate | A-S Medication Solutions | ANDA | Current |
| 60760-634 | metoprolol succinate | metoprolol succinate | St. Mary's Medical Park Pharmacy | ANDA | Current |
| 63629-9413 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 68071-2522 | metoprolol succinate | metoprolol succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68071-2651 | metoprolol succinate | metoprolol succinate | NuCare Pharmaceuticals,Inc. | ANDA | Current |
| 68382-564 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-564 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-564 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-564 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-565 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-565 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-565 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-565 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-566 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-566 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-566 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-566 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-567 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-567 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-567 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68382-567 | metoprolol succinate | metoprolol succinate | Zydus Pharmaceuticals (USA) Inc. | ANDA | Current |
| 68788-7997 | metoprolol succinate | metoprolol succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-7997 | metoprolol succinate | metoprolol succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8069 | metoprolol succinate | metoprolol succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8069 | metoprolol succinate | metoprolol succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8098 | metoprolol succinate | metoprolol succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 68788-8098 | metoprolol succinate | metoprolol succinate | Preferred Pharmaceuticals Inc. | ANDA | Current |
| 70518-3122 | metoprolol succinate | metoprolol succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3143 | metoprolol succinate | metoprolol succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3164 | metoprolol succinate | metoprolol succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3164 | metoprolol succinate | metoprolol succinate | REMEDYREPACK INC. | ANDA | Current |
| 70518-3164 | metoprolol succinate | metoprolol succinate | REMEDYREPACK INC. | ANDA | Current |
| 70771-1338 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1338 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1338 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1338 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1339 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1339 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1339 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1339 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1340 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1340 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1340 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1340 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1341 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1341 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1341 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 70771-1341 | metoprolol succinate | metoprolol succinate | Cadila Healthcare Limited | ANDA | Current |
| 71335-1875 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1875 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1875 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1878 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1878 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1878 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1951 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |
| 71335-1951 | metoprolol succinate | metoprolol succinate | Bryant Ranch Prepack | ANDA | Current |