USFDA APPLICATION NUMBER - 21038 / DOSAGE - INJECTABLE;INJECTION - EQ 200MCG BASE/2ML (EQ 100MCG 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 | Fresenius Kabi USA, LLC | Accord Healthcare Inc. | Actavis Pharma, Inc. | Athenex Pharmaceutical Division, LLC. | General Injectables and Vaccines, Inc. | Hikma Pharmaceuticals USA Inc. | Jiangsu Hengrui Medicine Co., Ltd. | Medical Purchasing Solutions, LLC | Mylan Institutional LLC | Sandoz Inc | Sandoz Inc. |
---|---|---|---|---|---|---|---|---|---|---|---|
ACETIC ACID(Q40Q9N063P) | |||||||||||
SODIUM ACETATE(4550K0SC9B) | |||||||||||
SODIUM CHLORIDE(451W47IQ8X) | |||||||||||
WATER(059QF0KO0R) |
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