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| INJECTABLE;INJECTION | EQ 0.1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| INJECTABLE;INJECTION | EQ 1MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | Yes | No |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| EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | |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HYDROCHLORIDE | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 |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 |
|---|---|---|---|---|---|---|---|---|---|
| 2022-10-28 04:53 UTC | 2022-10 | 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| REVEX | EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | f41ea6bd6efb… | |
| 2022-10-28 04:53 UTC | 2022-10 | 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| REVEX | EQ 2MG BASE/2ML (EQ 1MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SOLUTION / INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS | RLD | 1995-04-17 | f41ea6bd6efb… | |
| 2022-09-29 23:25 UTC | 2022-09 | 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 | e64feba35796… | |
| 2022-09-29 23:25 UTC | 2022-09 | 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 | e64feba35796… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | 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 | cb3db0bc1861… | |
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | 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 | cb3db0bc1861… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | 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 | a50c72e98297… | |
| 2026-07-26 02:55 UTC · 3 captures of this ZIP | 2026-06 | 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 | 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 |
|---|---|---|---|---|---|---|
| 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.