Application 007942
- Type
- NDA
- Sponsor
- FOREST LABS
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | SUS-PHRINE SULFITE FREE | EPINEPHRINE | INJECTABLE;INJECTION | 5MG/ML | No | No |
| 003 | SUS-PHRINE SULFITE FREE | EPINEPHRINE | INJECTABLE;INJECTION | 1.5MG/AMP | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N007942-001 | SUS-PHRINE SULFITE FREE | EPINEPHRINE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | ||
| N007942-003 | SUS-PHRINE SULFITE FREE | EPINEPHRINE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 |
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 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 84e616aacf4f… | ||
| 2026-09-14 22:38:34 | 2026-08 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | caaa826d4ba7… | ||
| 2026-08-18 06:07:40 | 2026-07 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 011fe1cb6892… | ||
| 2026-02-19 14:30 UTC | 2026-02 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 31067a03dcf5… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 6a471c1ec25d… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | fd3edfee7708… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | b8a1b40f171c… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 03ed91905a0d… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 2680178bc6a6… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5bbf6a4d5a75… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d8e5a09893c0… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | d06236e962d9… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 79d66fd596c7… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 301d65b070ca… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 1e350fbaab3a… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 8072bd15b7f6… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5c6f7cd8ea54… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 5d02ea3f76ae… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 4b0b4de00fa7… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N007942-001 | SUS-PHRINE SULFITE FREE | 5MG/ML | INJECTABLE / INJECTION | Approved before 1982 | 74a2ff9319b5… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N007942-003 | SUS-PHRINE SULFITE FREE | 1.5MG/AMP | INJECTABLE / INJECTION | 1999-02-05 | 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 |
|---|---|---|---|---|---|---|
| epinephrine | EPINEPHRINE | ASCLEMED USA INC. | 76f65a94-4b26-4c40-8a74-79a73afbb4e2 | 2025-09-04 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Redpharm Drug | 300ac735-4493-c02a-e063-6294a90a5bce | 2025-08-30 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | ProPharma Distribution | 3d728e53-92c2-114e-e063-6394a90ad404 | 2025-08-28 | Warnings, Adverse reactions | EPINEPHRINE |
| epinephrine | EPINEPHRINE | Gland Pharma Limited | b7b5e709-2125-4568-9a1d-9b4ea75d6c4a | 2025-06-03 | Warnings, Adverse reactions | EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | Amneal Pharmaceuticals Private Limited | 33fa2443-5c80-4967-98bb-f60d3144421c | 2025-05-14 | Warnings, Adverse reactions | EPINEPHRINE |
| neffy | EPINEPHRINE | Medical Purchasing Solutions, LLC | 2d4063e8-f56c-6902-e063-6294a90a0d40 | 2025-02-03 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine Convenience Kit | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 9df23744-3b5b-5815-e053-2a95a90acc47 | 2025-01-08 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Advanced Rx Pharmacy of Tennessee, LLC | f4d7aca4-0acd-74c2-e053-2995a90a9d94 | 2024-12-31 | Warnings, Adverse reactions | EPINEPHRINE |
| Auvi-Q | EPINEPHRINE | Medical Purchasing Solutions, LLC | 296a9023-b5c6-6102-e063-6294a90af87e | 2024-12-16 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | International Medication Systems, Limited | f2b5f15b-8541-466a-a27a-ee57bc4aac67 | 2024-12-16 | Warnings, Adverse reactions | EPINEPHRINE |
| Auvi-Q | EPINEPHRINE | Medical Purchasing Solutions, LLC | 29299266-69c5-b1a7-e063-6394a90a25f8 | 2024-12-13 | Warnings, Adverse reactions | EPINEPHRINE |
| epinephrine | EPINEPHRINE | Asclemed USA, Inc. | 0a29fe62-e241-4272-b91c-c1036b031cd4 | 2024-08-02 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | International Medication Systems, Limited | 7b6ffd77-8b25-4ff1-993e-dbfd7e0834cf | 2024-06-19 | Warnings, Adverse reactions | EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 98aaa648-fc25-754d-e053-2995a90a7051 | 2024-03-08 | Warnings, Adverse reactions | EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | 7664bb0d-dc1a-ca8b-e053-2991aa0ad627 | 2024-02-19 | Warnings, Adverse reactions | EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | c0d1def8-9f47-0d3e-e053-2995a90af955 | 2024-01-30 | Warnings, Adverse reactions | EPINEPHRINE |
| EPINEPHRINE | EPINEPHRINE | HF Acquisition Co LLC, DBA HealthFirst | f9c82678-5f4d-fded-e053-6394a90ac16d | 2024-01-22 | Warnings, Adverse reactions | EPINEPHRINE |
| Epinephrine | EPINEPHRINE | Bryant Ranch Prepack | a7ae17f8-de81-4de9-a89f-bb930c6a27ec | 2024-01-15 | Warnings, Adverse reactions | EPINEPHRINE |
| Adrenalinum | EPINEPHRINE | Boiron | 83fa46ed-ce86-5054-e053-2991aa0ab381 | 2023-12-21 | EPINEPHRINE | |
| Epinephrine | EPINEPHRINE | A-S Medication Solutions | b7a4171c-7934-4723-a140-bd93ea84aae1 | 2023-11-21 | Warnings, Adverse reactions | EPINEPHRINE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.