Application 018672
- Type
- NDA
- Sponsor
- POHL BOSKAMP
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITRONAL | NITROGLYCERIN | INJECTABLE;INJECTION | 1MG/ML | No | No |
| 002 | NITRO IV | NITROGLYCERIN | INJECTABLE;INJECTION | 5MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N018672-001 | NITRONAL | NITROGLYCERIN | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | ||
| N018672-002 | NITRO IV | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 |
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 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018672-001 | NITRONAL | 1MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N018672-002 | NITRO IV | 5MG/ML | INJECTABLE / INJECTION | 1983-08-30 | 74a2ff9319b5… |
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 |
|---|---|---|---|---|---|---|
| NITROLINGUAL | NITROGLYCERIN | INDEPENDENCE PHARMACEUTICALS, LLC | d19b5f51-ca85-48d6-9ccd-8ae26249cdc3 | 2024-05-13 | Warnings, Adverse reactions | NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Cosette Pharmaceuticals, Inc. | ac908e70-9425-4e9c-8c67-7b2882b40204 | 2024-02-21 | Warnings, Adverse reactions | NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Proficient Rx LP | 160b85ac-d964-463b-9f1e-1429f14ed318 | 2024-02-01 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Prasco Laboratories | f9731c86-34b0-42a2-8b39-eca907e02e74 | 2024-01-01 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | A-S Medication Solutions | fc297c0a-a412-40be-8414-4bf9906fd300 | 2023-12-11 | Warnings, Adverse reactions | NITROGLYCERIN |
| Glonoinum | NITROGLYCERIN | Boiron | 85a1163a-fe45-e31a-e053-2991aa0a6466 | 2023-11-13 | NITROGLYCERIN | |
| Glonoinum | NITROGLYCERIN | Boiron | 85a39d5c-2b11-62ed-e053-2a91aa0a0a31 | 2023-11-13 | NITROGLYCERIN | |
| Glonoinum | NITROGLYCERIN | Boiron | 85a33a5a-41c6-3d84-e053-2a91aa0a6ec7 | 2023-11-13 | NITROGLYCERIN | |
| Glonoinum | NITROGLYCERIN | Boiron | 7c0efc90-7a53-11e6-a302-424c58303031 | 2023-11-13 | NITROGLYCERIN | |
| NITROGLYCERIN | NITROGLYCERIN | Aurobindo Pharma Limited | 26c314ea-077e-490b-826b-2aafcb6e9564 | 2023-11-01 | Warnings, Adverse reactions | NITROGLYCERIN |
| Glonoinum | NITROGLYCERIN | Boiron | 85a47cfa-4d34-a596-e053-2a91aa0a02dc | 2023-10-30 | NITROGLYCERIN | |
| Glonoinum | NITROGLYCERIN | Boiron | 85a3b808-b45a-f2f0-e053-2a91aa0af21f | 2023-10-23 | NITROGLYCERIN | |
| NITROGLYCERIN | NITROGLYCERIN | Natco Pharma USA LLC | 941ac242-120e-47c1-ac03-50026ff93dd6 | 2023-07-20 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Medical Purchasing Solutions, LLC | 6671d89f-cc89-c03c-e053-2a91aa0aa5fa | 2023-06-05 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Medical Purchasing Solutions, LLC | 8959095a-8cd8-f7d4-e053-2995a90a6e8f | 2023-05-31 | Warnings, Adverse reactions | NITROGLYCERIN |
| NITRO-DUR | NITROGLYCERIN | Ingenus Pharmaceuticals, LLC | 5e15296c-5acd-4bcc-80a8-b49cb1ef3eb0 | 2023-05-30 | Boxed warning, Warnings, Adverse reactions | NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Medical Purchasing Solutions, LL | f9b52553-5a26-d374-e053-6294a90a40c7 | 2023-04-19 | Warnings, Adverse reactions | NITROGLYCERIN |
| Glonoinum | NITROGLYCERIN | Boiron | 85a3f76b-7b09-5d00-e053-2a91aa0ad1de | 2023-02-20 | NITROGLYCERIN | |
| Nitrostat | NITROGLYCERIN | Viatris Specialty LLC | 9a52da75-d0af-4237-96c0-0b12adfa8636 | 2023-02-15 | Warnings, Adverse reactions | NITROGLYCERIN |
| Glonoinum | NITROGLYCERIN | Boiron | 85a39643-ae56-f21e-e053-2991aa0a4915 | 2023-01-23 | NITROGLYCERIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.