Application 212854
- Type
- NDA
- Sponsor
- ADAMIS PHARMS CORP
Application Products#
Product, Drug, Ingredient table| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|
| 001 | ZIMHI | NALOXONE HYDROCHLORIDE | INJECTABLE;INJECTION | 5MG/0.5ML | No | No |
NDC Listings For This Application#
NDC, Name, Nonproprietary name table| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|
| 38739-600 | ZIMHI | Naloxone Hydrochloride | Adamis Pharmaceuticals | NDA | Current |
| 78670-140 | Zimhi | NALOXONE HYDROCHLORIDE | USWM, LLC | NDA | Current |
| 78670-140 | Zimhi | NALOXONE HYDROCHLORIDE | USWM, LLC | NDA | Current |
| 78670-140 | Zimhi | NALOXONE HYDROCHLORIDE | USWM, LLC | NDA | Current |
| 78670-140 | Zimhi | NALOXONE HYDROCHLORIDE | USWM, LLC | NDA | Current |
Documents#
Document, Submission type, Date table| Document | Submission type | Date |
|---|
| 71575 | ORIG | 2022-07-18 |
| 69028 | ORIG | 2021-10-19 |
| 69010 | ORIG | 2021-10-18 |