Drug application
ZIMHI (NALOXONE HYDROCHLORIDE)
Drugs@FDA NDA 212854 · ZMI PHARMA
Key facts
| Drug name | ZIMHI |
|---|---|
| Active ingredients | NALOXONE HYDROCHLORIDE |
| Application type | NDA |
| Application number | 212854 |
| Company | ZMI PHARMA |
| Dosage forms | SOLUTION, INTRAMUSCULAR, SUBCUTANEOUS |
| Strength | 5MG/0.5ML (5MG/0.5ML) |
| Marketing status | Prescription |
| Reference listed drug | Yes |
| Latest submission class | Type 5 - New Formulation or New Manufacturer |
| Latest submission status date | Oct 15, 2021 |
At a glance
- 1–9 Submissions
- 1–9 Label versions
- 1–9 Products
- None Therapeutic equivalents
- Yes FDA letters on file
- Yes FDA reviews on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About Drugs@FDA applications
Drugs@FDA covers FDA-approved brand-name and generic drugs and therapeutic biologics, with their applications (NDA, ANDA or BLA), products, submissions and labels.
Source: U.S. Food and Drug Administration (FDA), Drugs@FDA · Source date: