Application 020459
- Type
- NDA
- Sponsor
- EUROHLTH INTL SARL
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | REVEX | NALMEFENE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
| 002 | REVEX | NALMEFENE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N020459-001 | REVEX | NALMEFENE HYDROCHLORIDE | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | |
| N020459-002 | REVEX | NALMEFENE HYDROCHLORIDE | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 |
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 |
|---|---|---|---|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 74a2ff9319b5… | |
| 2019-12-13 00:20 UTC | 2019-12 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | bb7c543d1eb4… | |
| 2022-03-09 01:35 UTC | 2022-03 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 782e0a99824c… | |
| 2021-12-28 21:50 UTC | 2021-12 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 87673890dc5c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 5aa47cf7b7d7… | |
| 2021-03-12 10:30 UTC | 2021-03 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 8869cabd3fbd… | |
| 2020-12-22 03:56 UTC | 2020-12 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | c0c555d07b60… | |
| 2020-11-12 02:37 UTC | 2020-11 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 3f01610625f2… | |
| 2019-12-14 00:12 UTC | 2019-12 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | b00525d2431f… | |
| 2019-09-15 20:21 UTC | 2019-09 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020459-001 | REVEX | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | ea99ee380514… | |
| 2019-07-19 19:46 UTC | 2019-07 | N020459-002 | REVEX | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | INJECTABLE / INJECTION | RLD | 1995-04-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 6a51e52b5d6a… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 1c564ffb4f44… | |
| 2024-02-18 07:12 UTC | 2024-02 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | ea1830bbd6c7… | |
| 2023-12-20 04:57 UTC | 2023-12 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | a72a2bbeb626… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 9b2671bbb829… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | a67488948f0b… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 3f0d92c62455… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 053a50430f4f… | |
| 2023-05-13 08:27 UTC | 2023-05 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 3bdfa0b2c4d7… | |
| 2023-01-26 05:58 UTC | 2023-01 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020459-001 | REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 3a93d1ddd44b… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N020459-002 | REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | 3a93d1ddd44b… |
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 |
|---|---|---|---|---|---|---|
| Zurnai | NALMEFENE HYDROCHLORIDE | Knoa Pharma LLC | a59a5847-9fe4-4341-a203-be0a5e6d3e36 | 2026-07-31 | Warnings, Adverse reactions | NALMEFENE HYDROCHLORIDE |
| NALMEFENE HYDROCHLORIDE | NALMEFENE HYDROCHLORIDE | Knoa Pharma LLC | 3abfbffc-9e52-4fc6-ae92-6e0a97f4afe7 | 2026-05-01 | Warnings, Adverse reactions | NALMEFENE HYDROCHLORIDE |
| OPVEE | NALMEFENE HYDROCHLORIDE | Indivior Inc. | 999a4269-9e54-4801-b2ac-2a7276f0b94f | 2026-01-08 | Warnings, Adverse reactions | NALMEFENE HYDROCHLORIDE |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.