Application 205046
- Type
- ANDA
- Sponsor
- WEST-WARD PHARMS INT
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 |
|---|
| 0143-9532 | Dexmedetomidine HCl | Dexmedetomidine HCl | West-Ward Pharmaceuticals Corp | ANDA | Current |
| 0143-9532 | Dexmedetomidine HCl | Dexmedetomidine HCl | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9532 | Dexmedetomidine HCl | Dexmedetomidine HCl | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 0143-9532 | Dexmedetomidine HCl | Dexmedetomidine HCl | Hikma Pharmaceuticals USA Inc. | ANDA | Current |
| 71872-7218 | Dexmedetomidine HCl | Dexmedetomidine HCl | Medical Purchasing Solutions, LLC | ANDA | Current |