Application 216916
- Type
- ANDA
- Sponsor
- GRANULES
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 |
|---|---|---|---|---|---|---|---|
| A216916-001 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | |
| A216916-002 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | |
| A216916-003 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | |
| A216916-004 | METOPROLOL SUCCINATE | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 |
Therapeutic equivalence codes#
| Application-product | TE code |
|---|---|
| A216916-001 | AB |
| A216916-002 | AB |
| A216916-003 | AB |
| A216916-004 | 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 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-001 | METOPROLOL SUCCINATE | EQ 25MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-002 | METOPROLOL SUCCINATE | EQ 50MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-003 | METOPROLOL SUCCINATE | EQ 100MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-004 | METOPROLOL SUCCINATE | EQ 200MG TARTRATE | TABLET, EXTENDED RELEASE / ORAL | AB | 2023-06-12 | 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 | A216916-001 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216916-002 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216916-003 | AB | 1 | 011fe1cb6892… |
| 2026-02-19 14:30 UTC | 2026-02 | A216916-004 | AB | 1 | 011fe1cb6892… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-001 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-002 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-003 | AB | 1 | 31067a03dcf5… |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A216916-004 | AB | 1 | 31067a03dcf5… |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-001 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-002 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-003 | AB | 1 | 6a471c1ec25d… |
| 2025-08-23 18:47 UTC | 2025-08 | A216916-004 | AB | 1 | 6a471c1ec25d… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-001 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-002 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-003 | AB | 1 | fd3edfee7708… |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A216916-004 | AB | 1 | fd3edfee7708… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-001 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-002 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-003 | AB | 1 | b8a1b40f171c… |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A216916-004 | AB | 1 | b8a1b40f171c… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-001 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-002 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-003 | AB | 1 | 03ed91905a0d… |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A216916-004 | AB | 1 | 03ed91905a0d… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-001 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-002 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-003 | AB | 1 | 2680178bc6a6… |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A216916-004 | AB | 1 | 2680178bc6a6… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-001 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-002 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-003 | AB | 1 | 5bbf6a4d5a75… |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A216916-004 | AB | 1 | 5bbf6a4d5a75… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-001 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-002 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-003 | AB | 1 | d8e5a09893c0… |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A216916-004 | AB | 1 | d8e5a09893c0… |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-001 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-002 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-003 | AB | 1 | d06236e962d9… |
| 2024-10-29 15:01 UTC | 2024-10 | A216916-004 | 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 | PD-Rx Pharmaceuticals, Inc. | 98a39051-be63-4120-b247-50796656bd7c | 2026-07-02 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Proficient Rx LP | d7f6200f-d600-4a13-9434-b77f99057ae8 | 2026-06-01 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | a3aadb05-74e1-4c73-906c-be64f5242d36 | 2026-05-21 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Redpharm Drug | 301ec2ea-84cb-ad89-e063-6294a90af49d | 2026-04-21 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Proficient Rx LP | 9bd9ff03-7c11-41c9-9054-126313d10506 | 2026-04-01 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | NuCare Pharmaceuticals,Inc. | 4a900d2c-12d1-6bfa-e063-6294a90af009 | 2026-02-11 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Northwind Health Company, LLC | 471f154c-197f-31df-e063-6394a90ae73e | 2026-01-12 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Northwind Health Company, LLC | 471bdbd7-7435-6786-e063-6294a90aa8a0 | 2025-12-29 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Northwind Health Company, LLC | 47202157-3f32-275d-e063-6294a90a5c44 | 2025-12-29 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | REMEDYREPACK INC. | a46cbf09-20e3-4f0d-ab41-221f60fde068 | 2025-12-09 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate ER | METOPROLOL SUCCINATE ER | DIrect_Rx | 45723206-1a9d-5299-e063-6294a90ad969 | 2025-12-08 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | REMEDYREPACK INC. | a34ba95a-a2d5-400e-8757-58c7bd20cad7 | 2025-12-04 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Proficient Rx LP | f2d7c4da-9df0-44d4-9db3-e47e9cce9254 | 2025-12-01 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | 57e12147-af06-421a-a2d6-99f0a0ce2b0e | 2025-10-28 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | 8b77b979-292c-43a0-a739-8ba028d5457c | 2025-10-14 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Preferred Pharmaceuticals Inc. | 27bb8bd5-b3ae-4eb3-b508-5684904408be | 2025-09-05 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | 5223b690-0ccd-4ec4-b83b-22ce392713b2 | 2025-07-03 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | A-S Medication Solutions | 4da96d34-ae8e-4c63-8ba0-bbeefdc20516 | 2025-07-03 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Bryant Ranch Prepack | 75f6c399-7a55-49a2-a8bb-dec534e37548 | 2025-06-04 | Warnings, Adverse reactions | 216916 ANDA216916 |
| Metoprolol Succinate | METOPROLOL SUCCINATE | Preferred Pharmaceuticals Inc. | 21e18c1c-fabb-44a4-a33a-b02a47967d73 | 2025-04-30 | Warnings, Adverse reactions | 216916 ANDA216916 |