warnings
Warning When using this product some people may experience symptoms when they wake up, such as, shaking, sweating, nausea, or feeling angry. This is to be expected.
Application 071084
- Type
- ANDA
- Sponsor
- BRISTOL MYERS SQUIBB
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | NARCAN | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 1MG/ML | No | No |
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A071084-001 | NARCAN | NALOXONE HYDROCHLORIDE | 1MG/ML | INJECTABLE / INJECTION | 1988-07-28 |
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Sportpharm LLC | 3d43b2a2-9cc3-4c14-8ae7-fea4c83a7f92 | 2026-04-24 | Warnings | |
| NARCAN | NALOXONE HYDROCHLORIDE NASAL | Emergent Devices Inc. | a0ebc83d-2892-40de-bc0a-775ce90b30db | 2026-04-22 | Warnings | |
| Narcan | NALOXONE HYDROCHLORIDE | Emergent Devices Inc. | 724df050-5332-4d0a-9a5f-17bf08a547e1 | 2025-12-05 | Warnings, Adverse reactions | |
| NARCAN | NALOXONE HYDROCHLORIDE | A-S Medication Solutions | 139c30b9-5600-48f5-8610-0cacd2782398 | 2023-09-28 | Warnings, Adverse reactions | |
| Narcan | NALOXONE HYDROCHLORIDE | Proficient Rx LP | 76b5a1ce-e601-457c-ab35-43533bba4394 | 2022-08-01 | Warnings, Adverse reactions |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.