Application 211363
- Type
- NDA
- Sponsor
- INTL MEDICATION SYS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | EPINEPHRINE | EPINEPHRINE | INJECTABLE;INJECTION | 1MG/10ML(0.1MG/ML) | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N211363-001 | EPINEPHRINE | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 |
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 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 8072bd15b7f6… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | e64feba35796… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | N211363-001 | EPINEPHRINE | 1MG/10ML (0.1MG/ML) | SOLUTION / INTRAVENOUS | RLD, RS | 2022-08-15 | a50c72e98297… |
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 |
|---|---|---|---|---|---|---|
| Epinephrine | EPINEPHRINE | A-S Medication Solutions | 6e811e28-0199-4df7-a916-5940c632401d | 2026-07-13 | Warnings, Adverse reactions | 211363 NDA211363 |
| Epinephrine | EPINEPHRINE | REMEDYREPACK INC. | 0172280c-f7d6-4613-9dbd-f94d3ae5825a | 2026-06-08 | Warnings, Adverse reactions | 211363 NDA211363 |
| EPINEPHRINE | EPINEPHRINE | Henry Schein, Inc. | 3b1ac82f-6920-4e40-a77e-598398679f2d | 2025-10-31 | Warnings, Adverse reactions | 211363 NDA211363 |
| Epinephrine | EPINEPHRINE | ProPharma Distribution | 3d728e53-92c2-114e-e063-6394a90ad404 | 2025-08-28 | Warnings, Adverse reactions | 211363 NDA211363 |
| Epinephrine | EPINEPHRINE | International Medication Systems, Limited | f2b5f15b-8541-466a-a27a-ee57bc4aac67 | 2024-12-16 | Warnings, Adverse reactions | 211363 NDA211363 |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | f9c82678-5f4d-fded-e053-6394a90ac16d | 2024-01-22 | Warnings, Adverse reactions | 211363 NDA211363 |
| Epinephrine | EPINEPHRINE | Medical Purchasing Solutions, LLC | 093312af-6eed-1f4b-e063-6294a90a155d | 2023-11-02 | Warnings, Adverse reactions | 211363 NDA211363 |