
USFDA APPLICATION NUMBER - 203049 / DOSAGE - INJECTABLE;INJECTION - 250MG/2.5ML (100MG/ML)
| Active Ingredient/Active Moiety | ||
| Ingredient Name | Basis of Strength | Strength |
|---|---|---|
| ARGATROBAN(UNII: IY90U61Z3S) (ARGATROBAN ANHYDROUS - UNII:OCY3U280Y3) | ARGATROBAN ANHYDROUS | 250mg in 2.5 | 50mg in 50 |
Inactive Ingredients
| Ingredient Name | Amneal Pharmaceuticals LLC | Glaxo Operations UK Ltd | GlaxoSmithKline LLC | Hikma Pharmaceuticals USA Inc. | Novartis Pharmaceuticals Corporation | Par Pharmaceutical, Inc. |
|---|---|---|---|---|---|---|
| ALCOHOL(3K9958V90M) | ||||||
| PROPYLENE GLYCOL(6DC9Q167V3) | ||||||
| SODIUM CHLORIDE(451W47IQ8X) | ||||||
| SORBITOL(506T60A25R) | ||||||
| WATER(059QF0KO0R) |