Application 204843
- Type
- ANDA
- Sponsor
- CIPLA
Application Products#
| Product | Drug | Ingredient | Form | Strength | Reference drug | Reference standard |
|---|---|---|---|---|---|---|
| 001 | DEXMEDETOMIDINE HYDROCHLORIDE | DEXMEDETOMIDINE HYDROCHLORIDE | INJECTABLE;INJECTION | EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) | No | No |
NDC Listings For This Application#
| NDC | Name | Nonproprietary name | Labeler | Marketing category | Status |
|---|---|---|---|---|---|
| 71288-505 | DEXMEDETOMIDINE | DEXMEDETOMIDINE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-505 | DEXMEDETOMIDINE | DEXMEDETOMIDINE | Meitheal Pharmaceuticals Inc. | ANDA | Current |
| 71288-505 | DEXMEDETOMIDINE | DEXMEDETOMIDINE | Meitheal Pharmaceuticals Inc. | ANDA | Current |