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Setid 0cdf3f67 5bf3 4d58 B330 03febdc652bf Applno 203049 Form Injectable Injection Dosage 250mg 2 5ml 100mg Ml - Drug Product Composition: Argatroban

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$ API Ref.Price (USD/KG) : 86,526Xls

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 ANHYDROUS250mg 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)