Application 012836
- Type
- NDA
- Sponsor
- BOEHRINGER INGELHEIM
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | PERSANTINE | DIPYRIDAMOLE | TABLET;ORAL | 25MG | Yes | No |
| 004 | PERSANTINE | DIPYRIDAMOLE | TABLET;ORAL | 50MG | Yes | No |
| 005 | PERSANTINE | DIPYRIDAMOLE | TABLET;ORAL | 75MG | Yes | Yes |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012836-003 | PERSANTINE | DIPYRIDAMOLE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-12-22 | |
| N012836-004 | PERSANTINE | DIPYRIDAMOLE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | |
| N012836-005 | PERSANTINE | DIPYRIDAMOLE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 |
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| 2026-08 | N012836-003 | PERSANTINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-12-22 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012836-004 | PERSANTINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N012836-005 | PERSANTINE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N012836-003 | PERSANTINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-12-22 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012836-004 | PERSANTINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N012836-005 | PERSANTINE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012836-003 | PERSANTINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-12-22 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012836-004 | PERSANTINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012836-005 | PERSANTINE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012836-003 | PERSANTINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-12-22 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012836-004 | PERSANTINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012836-005 | PERSANTINE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012836-003 | PERSANTINE | 25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1986-12-22 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012836-004 | PERSANTINE | 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012836-005 | PERSANTINE | 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / ORAL | RLD | 1987-02-06 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012836-004 | PERSANTINE | 50MG | TABLET / ORAL | RLD | 1987-02-06 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012836-005 | PERSANTINE | 75MG | TABLET / ORAL | RLD | 1987-02-06 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012836-003 | PERSANTINE | 25MG | TABLET / ORAL | RLD | 1986-12-22 | 301d65b070ca… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-07-19 19:46 UTC | 2019-07 | N012836-004 | AB | 1 | ea99ee380514… |
| 2019-07-19 19:46 UTC | 2019-07 | N012836-005 | AB | 1 | ea99ee380514… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012836-003 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012836-004 | AB | 1 | 6a51e52b5d6a… |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N012836-005 | AB | 1 | 6a51e52b5d6a… |
| 2024-02-18 07:12 UTC | 2024-02 | N012836-003 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N012836-004 | AB | 1 | 1c564ffb4f44… |
| 2024-02-18 07:12 UTC | 2024-02 | N012836-005 | AB | 1 | 1c564ffb4f44… |
| 2023-12-20 04:57 UTC | 2023-12 | N012836-003 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N012836-004 | AB | 1 | ea1830bbd6c7… |
| 2023-12-20 04:57 UTC | 2023-12 | N012836-005 | AB | 1 | ea1830bbd6c7… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012836-003 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012836-004 | AB | 1 | a72a2bbeb626… |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N012836-005 | AB | 1 | a72a2bbeb626… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012836-003 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012836-004 | AB | 1 | 9b2671bbb829… |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N012836-005 | AB | 1 | 9b2671bbb829… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012836-003 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012836-004 | AB | 1 | a67488948f0b… |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N012836-005 | AB | 1 | a67488948f0b… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012836-003 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012836-004 | AB | 1 | 3f0d92c62455… |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N012836-005 | AB | 1 | 3f0d92c62455… |
| 2023-05-13 08:27 UTC | 2023-05 | N012836-003 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N012836-004 | AB | 1 | 053a50430f4f… |
| 2023-05-13 08:27 UTC | 2023-05 | N012836-005 | AB | 1 | 053a50430f4f… |
| 2023-01-26 05:58 UTC | 2023-01 | N012836-003 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N012836-004 | AB | 1 | 3bdfa0b2c4d7… |
| 2023-01-26 05:58 UTC | 2023-01 | N012836-005 | AB | 1 | 3bdfa0b2c4d7… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012836-003 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012836-004 | AB | 1 | 3a93d1ddd44b… |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N012836-005 | AB | 1 | 3a93d1ddd44b… |
| 2022-10-28 04:53 UTC | 2022-10 | N012836-003 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N012836-004 | AB | 1 | f41ea6bd6efb… |
| 2022-10-28 04:53 UTC | 2022-10 | N012836-005 | AB | 1 | f41ea6bd6efb… |
| 2022-09-29 23:25 UTC | 2022-09 | N012836-003 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N012836-004 | AB | 1 | e64feba35796… |
| 2022-09-29 23:25 UTC | 2022-09 | N012836-005 | AB | 1 | e64feba35796… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N012836-003 | AB | 1 | cb3db0bc1861… |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N012836-004 | AB | 1 | cb3db0bc1861… |
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 |
|---|---|---|---|---|---|---|
| Dipyridamole | DIPYRIDAMOLE | Hikma Pharmaceuticals USA Inc. | 6093dcd9-82d2-414f-8507-eda22c14f626 | 2026-05-20 | Warnings, Adverse reactions | DIPYRIDAMOLE |
| Dipyridamole | DIPYRIDAMOLE | REMEDYREPACK INC. | 226099e2-70bb-4b9b-bb52-c20fbca2aec5 | 2026-04-29 | Adverse reactions | DIPYRIDAMOLE |
| Dipyridamole | DIPYRIDAMOLE | Amneal Pharmaceuticals of New York LLC | a18b2af5-7c4a-4b7f-92c7-8a76e34da373 | 2026-04-15 | Adverse reactions | DIPYRIDAMOLE |
| Dipyridamole | DIPYRIDAMOLE | Henry Schein, Inc. | 1a2c0a9a-c637-4485-ad4b-0b6d0b05fa20 | 2025-10-30 | Warnings, Adverse reactions | DIPYRIDAMOLE |
| DIPYRIDAMOLE | DIPYRIDAMOLE | HF Acquisition Co LLC, DBA HealthFirst | 9bd34108-9d98-c4ca-e053-2995a90a2bc8 | 2025-01-08 | Warnings, Adverse reactions | DIPYRIDAMOLE |
| Dipyridamole | DIPYRIDAMOLE | Zydus Lifesciences Limited | 312aadb1-435c-4aa7-8e46-6506cedacaa0 | 2024-11-26 | DIPYRIDAMOLE | |
| Dipyridamole | DIPYRIDAMOLE | Zydus Pharmaceuticals USA Inc. | 004bada0-dbf7-4a94-8792-6833d7eeda2b | 2023-09-16 | Adverse reactions | DIPYRIDAMOLE |
| Dipyridamole | DIPYRIDAMOLE | Oxford Pharmaceuticals, LLC | f7ffd78a-e93a-40f4-8193-2d6ab4dafd00 | 2021-03-29 | Adverse reactions | DIPYRIDAMOLE |
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 |
|---|---|---|---|---|---|
| 0597-0017 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0017 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0018 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0018 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0019 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 0597-0019 | Persantine | dipyridamole | Boehringer Ingelheim Pharmaceuticals, Inc. | NDA | Current |
| 68151-2996 | Dipyridamole | Dipyridamole | Carilion Materials Management | NDA AUTHORIZED GENERIC | Current |