| Application # | Type | Sponsor | Notes | Product # | Drug Name | Form | Strength | Active Ingredient | Approval Date | Marketing Status | Reference Standard |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 208411 | NDA | EMERGENT | 001 | NARCAN | SPRAY, METERED;NASAL | 4MG/SPRAY | NALOXONE HYDROCHLORIDE | 2015-11-18 | Over-the-counter | Yes | |
| 002 | NARCAN | SPRAY, METERED;NASAL | 2MG/SPRAY **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | NALOXONE HYDROCHLORIDE | 2015-11-18 | Discontinued | No | ||||
| 021538 | BLA | EMERGENT | 001 | ACCRETROPIN | INJECTABLE;INJECTION | 5MG/ML (5MG/ML) | SOMATROPIN | 2008-01-23 | Discontinued | No |