Application 012940
- Type
- NDA
- Sponsor
- BIOVAIL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 003 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 004 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 005 | ISORDIL | ISOSORBIDE DINITRATE | TABLET;SUBLINGUAL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N012940-003 | ISORDIL | ISOSORBIDE DINITRATE | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | |
| N012940-004 | ISORDIL | ISOSORBIDE DINITRATE | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | |
| N012940-005 | ISORDIL | ISOSORBIDE DINITRATE | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 |
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UTC | 2026-02 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 011fe1cb6892… | |
| 2026-02-19 14:30 UTC | 2026-02 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 31067a03dcf5… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 6a471c1ec25d… | |
| 2025-08-23 18:47 UTC | 2025-08 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | fd3edfee7708… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | b8a1b40f171c… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 03ed91905a0d… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 2680178bc6a6… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 5bbf6a4d5a75… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | d8e5a09893c0… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | d06236e962d9… | |
| 2024-10-29 15:01 UTC | 2024-10 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 79d66fd596c7… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 301d65b070ca… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012940-004 | ISORDIL | 2.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 1e350fbaab3a… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N012940-005 | ISORDIL | 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N012940-003 | ISORDIL | 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET / SUBLINGUAL | RLD | 1988-07-29 | 8072bd15b7f6… |
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 |
|---|---|---|---|---|---|---|
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Par Health USA, LLC | 6df6a2fa-c56c-4eb6-a485-c16585420eb0 | 2026-07-31 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Par Health USA, LLC | 3d6164d7-3083-41c5-a6a6-7e144fe29f7d | 2026-07-22 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Cardinal Health 107, LLC | 5f585259-59ed-4648-b562-164f3746c821 | 2026-05-19 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Major Pharmaceuticals | 6c4997e7-9ce6-46a6-a9c1-4bd3d76155eb | 2026-03-13 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | AvPAK | 0e5842f2-74f6-1f02-01bc-07578bd3b393 | 2026-02-10 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | REMEDYREPACK INC. | 829ed058-333f-453c-9f0e-9202e03acf97 | 2026-01-08 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Golden State Medical Supply, Inc. | 7f860fbd-f130-4652-e053-2991aa0a402e | 2026-01-08 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | Advagen Pharma Ltd | b166eb5b-bad8-4663-9c05-1c43539dab2c | 2026-01-05 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Hikma Pharmaceuticals USA Inc. | f0b9b320-0bf8-4342-b654-135ccb6755c2 | 2025-12-05 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | American Health Packaging | 5c94ecc0-fcaa-4af3-82c2-ff124f2df3e1 | 2025-10-15 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | Northstar Rx LLC | 246c749d-aa28-44ce-8d42-984660afff2a | 2025-08-21 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Bryant Ranch Prepack | 73a1e6c0-71d0-4ba1-bbca-c067479e487d | 2024-10-08 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | BluePoint Laboratories | f1d52e9a-8de1-61db-e053-2a95a90aae50 | 2024-09-17 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | Zydus Pharmaceuticals (USA) Inc. | 16818b32-ee5e-4e07-b848-31e892c4b98a | 2024-08-08 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | Proficient Rx LP | 1cf9b6dd-9d4e-4ea1-95ae-e9e46a3d1b20 | 2024-08-01 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | Proficient Rx LP | 33d14f59-3ae8-4414-b826-06274cf0f3d9 | 2024-07-01 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Sandoz Inc. | 71fdd147-a987-40b6-9f07-82d56525ceb8 | 2024-02-01 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide dinitrate | ISOSORBIDE DINITRATE | Zydus Lifesciences Limited | 5b0db8af-bcf9-458f-b752-420130cba428 | 2023-11-07 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| ISOSORBIDE DINITRATE | ISOSORBIDE DINITRATE | NCS HealthCare of KY, LLC dba Vangard Labs | 74a7f767-fa2f-4640-be24-34a8a9128217 | 2023-05-22 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
| Isosorbide Dinitrate | ISOSORBIDE DINITRATE | Oceanside Pharmaceuticals | 723d9f78-9d77-4575-af27-1aa117e6b8d7 | 2020-03-02 | Warnings, Adverse reactions | ISOSORBIDE DINITRATE |
Documents#
| Document | Submission type | Date |
|---|---|---|
| 12042 | SUPPL | 2001-09-16 |