Application 071492
- Type
- ANDA
- Sponsor
- LUITPOLD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NITROGLYCERIN | 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 |
|---|---|---|---|---|---|---|---|
| A071492-001 | NITROGLYCERIN | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 |
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 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A071492-001 | NITROGLYCERIN | 5MG/ML | INJECTABLE / INJECTION | 1988-05-24 | 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 |
|---|---|---|---|---|---|---|
| Nitroglycerin | NITROGLYCERIN | Solaris Pharma Corporation | f0a76edb-9e63-4aa4-9362-7375c799b2b5 | 2025-12-22 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| Nitroglycerin In Dextrose | NITROGLYCERIN | ProPharma Distribution | 3f2c9570-a544-1982-e063-6294a90a3067 | 2025-12-18 | Warnings, Adverse reactions | NITROGLYCERIN |
| NITROGLYCERIN LINGUAL | NITROGLYCERIN | Allegis Pharmaceuticals, LLC | fadd07b7-189b-4678-ad0f-bf1e4d3d1300 | 2025-12-17 | Warnings, Adverse reactions | NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Henry Schein, Inc. | 578d8159-5ec6-457f-b4a8-9add624d43a8 | 2025-11-06 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | 422b4713-9531-f1bf-e063-6294a90ada2b | 2025-10-27 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Encube Ethicals, Inc. | 7bcead76-a90f-4140-9c73-4339d981a084 | 2025-09-26 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| nitroglycerin | NITROGLYCERIN | Medical Purchasing Solutions, LLC | 3f7ebc5e-82a7-393d-e063-6394a90a173a | 2025-09-23 | Warnings, Adverse reactions | nitroglycerin NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Redpharm Drug | 3dd022d8-c224-d19f-e063-6394a90adca4 | 2025-09-02 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | ProPharma Distribution | 3d71f76d-bb22-7251-e063-6394a90aa9d8 | 2025-08-28 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | 9453bd8b-5d54-5dc8-e053-2995a90a95b2 | 2025-06-16 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Solco Healthcare U.S., LLC | 61759752-dd07-4bed-8079-b578e3930519 | 2025-04-30 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| nitroglycerin | NITROGLYCERIN | NorthStar RxLLC | 141b6098-dd8e-4c99-a581-197d46f9e0b1 | 2025-01-17 | Warnings, Adverse reactions | nitroglycerin NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | NuCare Pharmaceuticals, Inc. | 2bad7976-4eb0-d064-e063-6394a90a75de | 2025-01-14 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | HF Acquisition Co LLC, DBA HealthFirst | c20e89b4-57b5-259d-e053-2a95a90a0038 | 2025-01-08 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| nitroglycerin | NITROGLYCERIN | Lifestar Pharma LLC | 38059df3-be1b-4226-9f12-c3c37cb44fea | 2024-12-30 | Warnings, Adverse reactions | nitroglycerin NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Trupharma, LLC | 543ef8c8-d520-461b-bf6e-f8d8c277feec | 2024-12-03 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | Mylan Pharmaceuticals Inc. | 041f127e-5166-4484-bc1a-0a373d1187ae | 2024-10-15 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| NITROSTAT | NITROGLYCERIN | A-S Medication Solutions | f7059ff7-bf74-48b4-811d-6eb1c26bfd8b | 2024-08-05 | Warnings, Adverse reactions | NITROGLYCERIN |
| NITROGLYCERIN | NITROGLYCERIN | NuCare Pharmaceuticals,Inc. | f4ea9ad1-a71f-7cea-e053-2a95a90a106d | 2024-07-22 | Warnings, Adverse reactions | NITROGLYCERIN NITROGLYCERIN |
| Nitroglycerin | NITROGLYCERIN | Proficient Rx LP | 41fe1f25-bfd0-4eaf-973d-bdb6b5d70f93 | 2024-07-01 | Warnings, Adverse reactions | Nitroglycerin NITROGLYCERIN |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.