Application 019091
- Type
- NDA
- Sponsor
- PROMIUS PHARMA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ISMO | ISOSORBIDE MONONITRATE | TABLET;ORAL | 20MG | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019091-001 | ISMO | ISOSORBIDE MONONITRATE | 20MG | TABLET / ORAL | 1991-12-30 |
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 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019091-001 | ISMO | 20MG | TABLET / ORAL | 1991-12-30 | f41ea6bd6efb… |
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 MONONITRATE | ISOSORBIDE MONONITRATE | NCS HealthCare of KY, LLC dba Vangard Labs | ba6120c8-c885-4cfa-b68e-9eee7a3bad6d | 2024-08-13 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | NCS HealthCare of KY, LLC dba Vangard Labs | 63dc518f-4f86-4820-98c2-5de8aed09a4b | 2024-08-13 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | NuCare Pharmaceuticals,Inc. | 65935a15-a023-1941-e053-2991aa0a5eb4 | 2024-06-06 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 17525ff2-9ec0-15a1-e063-6394a90ab762 | 2024-04-30 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Bryant Ranch Prepack | 441ddd35-6cb8-44d0-8009-1635390ede83 | 2024-04-03 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 0af6c67f-919d-4515-8074-f6c3aaa835b5 | 2024-02-06 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Aphena Pharma Solutions - Tennessee, LLC | 18cf36bc-e73f-4274-b381-c2f2aa02f57d | 2024-02-06 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | A-S Medication Solutions | adcca9b8-0505-4bbc-81ab-05efc7407b6b | 2024-01-23 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | A-S Medication Solutions | 4da5a0ac-574d-48ea-80ba-55344bfefb91 | 2023-12-09 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | A-S Medication Solutions | 44a0f691-b826-4580-ab2d-b5d1cc99e283 | 2023-11-09 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Ingenus Pharmaceuticals, LLC | c950760f-0e32-483f-96f2-eecaf057c0ec | 2023-10-27 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Bryant Ranch Prepack | 96420729-2bc7-4d03-9c51-f786ea678998 | 2023-10-26 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | A-S Medication Solutions | 5a8164a3-56e2-4b9b-8718-0423b4b4958f | 2023-09-05 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| ISOSORBIDE MONONITRATE | ISOSORBIDE MONONITRATE | Aurobindo Pharma Limited | 55810c9d-1140-40b8-a297-210a84afc05a | 2022-11-11 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| Isosorbide Mononitrate | ISOSORBIDE MONONITRATE | Actavis Pharma, Inc. | ae8f74f0-e600-4452-8557-958b603e2709 | 2022-10-01 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| isosorbide mononitrate | ISOSORBIDE MONONITRATE | Lannett Company, Inc. | bf9e7e35-7707-42a0-88d6-6292fa52bbfa | 2020-06-05 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
| isosorbide mononitrate | ISOSORBIDE MONONITRATE | Proficient Rx LP | f871dfa7-219f-4704-8e4d-215caeb7408d | 2019-11-01 | Warnings, Adverse reactions | ISOSORBIDE MONONITRATE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.