Application 210303
- Type
- NDA
- Sponsor
- CIPLA USA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | ZEMDRI | PLAZOMICIN SULFATE | SOLUTION;INTRAVENOUS | EQ 500MG BASE/10ML (EQ 50MG BASE/ML) | Yes | Yes |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 69097-820 | Zemdri (plazomicin) | Plazomicin | Cipla USA Inc. | NDA | Current |
| 69097-820 | Zemdri (plazomicin) | Plazomicin | Cipla USA Inc. | NDA | Current |
| 71045-010 | Zemdri (plazomicin) | Plazomicin | Achaogen, Inc. | NDA | Current |
| 80735-820 | Zemdri (plazomicin) | Plazomicin | Cipla Therapeutics Inc. | NDA | Current |