USFDA APPLICATION NUMBER - 21038 / DOSAGE - INJECTABLE;INJECTION - EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML)
Active Ingredient/Active Moiety | ||
Ingredient Name | Basis of Strength | Strength |
---|---|---|
DEXMEDETOMIDINE HYDROCHLORIDE(UNII: 1018WH7F9I) (DEXMEDETOMIDINE - UNII:67VB76HONO) | DEXMEDETOMIDINE | 100ug in 1 |
Inactive Ingredients
Ingredient Name | Baxter Healthcare Company | Athenex Pharmaceutical Division, LLC. | General Injectables and Vaccines, Inc. | Hikma Pharmaceuticals USA Inc. | Jiangsu Hengrui Medicine Co., Ltd. | Mylan Institutional LLC | Sandoz Inc. |
---|---|---|---|---|---|---|---|
ACETIC ACID(Q40Q9N063P) | |||||||
SODIUM ACETATE(4550K0SC9B) | |||||||
SODIUM CHLORIDE(451W47IQ8X) | |||||||
WATER(059QF0KO0R) |
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