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Setid Dc61c457 0ebe 4cd1 85ac 2830a1b09784 Applno 50606 Form Capsule Oral Dosage Eq 250mg Base - Drug Product Composition: Vancomycin Hydrochloride

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$ API Ref.Price (USD/KG) : 604Xls

USFDA APPLICATION NUMBER - 50606 / DOSAGE - CAPSULE;ORAL - EQ 250MG BASE

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VANCOMYCIN HYDROCHLORIDE(UNII: 71WO621TJD)
(VANCOMYCIN - UNII:6Q205EH1VU)
VANCOMYCIN125mg | 250mg

Inactive Ingredients

Ingredient Name
Orient Pharma Co.,Ltd Yunlin Plant
PAI Holdings, LLC
APP Pharmaceuticals, LLC
Fresenius Kabi USA, LLC
Lupin Pharmaceuticals, Inc.
Prasco Laboratories
CARNAUBA WAX(R12CBM0EIZ)    
FD&C BLUE NO. 1(H3R47K3TBD)    
FD&C BLUE NO. 2(L06K8R7DQK)  
FD&C RED NO. 40(WZB9127XOA)     
FD&C YELLOW NO. 5(I753WB2F1M)    
FD&C YELLOW NO. 6(H77VEI93A8)     
FERRIC OXIDE RED(1K09F3G675)     
FERRIC OXIDE YELLOW(EX438O2MRT) 
FERROSOFERRIC OXIDE(XM0M87F357)   
GELATIN(2G86QN327L)
GLYCERYL MONOOLEATE(C4YAD5F5G6)    
POLYETHYLENE GLYCOL 6000(30IQX730WE)     
POLYETHYLENE GLYCOL, UNSPECIFIED(3WJQ0SDW1A)    
POLYETHYLENE GLYCOLS(3WJQ0SDW1A)   
POTASSIUM HYDROXIDE(WZH3C48M4T)     
PROPYLENE GLYCOL(6DC9Q167V3)     
SHELLAC(46N107B71O)   
SODIUM LAURYL SULFATE(368GB5141J)   
TITANIUM DIOXIDE(15FIX9V2JP)