Application 216359
- Type
- NDA
- Sponsor
- RAFA LABS LTD
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | MIDAZOLAM | MIDAZOLAM | INJECTABLE;AUTOINJECTOR | 10MG/0.7ML | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71053-595 | N/A | Midazolam Injection, 10 mg | Rafa Laboratories, Ltd. | NDA | Current |