
USFDA APPLICATION NUMBER - 22434 / DOSAGE - INJECTABLE;INTRAVENOUS - 50MG/50ML (1MG/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| Argatroban(UNII: IY90U61Z3S) (Argatroban Anhydrous - UNII:OCY3U280Y3) | Argatroban Anhydrous | 1mg in 1 |
Inactive Ingredients
| Ingredient Name | Eagle Pharmaceuticals, Inc. | Sandoz Inc |
|---|---|---|
| Lactobionic acid(65R938S4DV) | ||
| Methionine(AE28F7PNPL) | ||
| Sodium Chloride(451W47IQ8X) |