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Setid 7984a4bc A17d 4909 9e8f 1d407b0307d0 Applno 50710 Form For Suspension Oral Dosage Eq 100mg Base 5ml - Drug Product Composition: Azithromycin

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$ API Ref.Price (USD/KG) : 194Xls

USFDA APPLICATION NUMBER - 50710 / DOSAGE - FOR SUSPENSION;ORAL - EQ 100MG BASE/5ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AZITHROMYCIN DIHYDRATE(UNII: 5FD1131I7S)
(AZITHROMYCIN ANHYDROUS - UNII:J2KLZ20U1M)
AZITHROMYCIN ANHYDROUS100mg in 5

Inactive Ingredients

Ingredient Name
A-S Medication Solutions
Preferred Pharmaceuticals, Inc.
Teva Pharmaceuticals USA, Inc.
NuCare Pharmaceuticals,Inc.
Preferred Pharmaceuticals Inc.
Proficient Rx LP
Quality Care Products LLC
Quality Care Products, LLC
RPK Pharmaceuticals, Inc.
Clinical Solutions Wholesale
Lake Erie Medical DBA Quality Care Products LLC
REMEDYREPACK INC.
STATE HEALTH SERVICES, TEXAS DEPARTMENT OF
Rebel Distributors Corp.
Amneal Pharmaceuticals LLC
Lupin Pharmaceuticals,Inc.
Zydus Pharmaceuticals USA Inc.
ACACIA(5C5403N26O)              
BANANA(4AJZ4765R9)         
CHERRY(BUC5I9595W)         
DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER(905HNO1SIH)         
ETHYL VANILLIN(YC9ST449YJ)             
FD&C RED NO. 40(WZB9127XOA) 
HYDROXYPROPYL CELLULOSE (120000 MW)(UKE75GEA7F)                
HYDROXYPROPYL CELLULOSE (1200000 MW)(RFW2ET671P)              
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(RFW2ET671P)      
HYDROXYPROPYL CELLULOSE (90000 WAMW)(UKE75GEA7F)             
HYDROXYPROPYL CELLULOSE (TYPE H)(RFW2ET671P)              
hydroxypropyl cellulose(RFW2ET671P)                
HYDROXYPROPYL CELLULOSE, UNSPECIFIED(9XZ8H6N6OH)                
MALTODEXTRIN(7CVR7L4A2D)             
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)(461P5CJN6T)             
SILICON DIOXIDE(ETJ7Z6XBU4)   
SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS(SX01TZO3QZ)   
SODIUM PHOSPHATE, TRIBASIC, DODECAHYDRATE(B70850QPHR)             
SUCROSE(C151H8M554)
TRIBASIC SODIUM PHOSPHATE(A752Q30A6X)                
VANILLIN(CHI530446X)             
XANTHAN GUM(TTV12P4NEE)