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Drug Product Composition: Folic Acid

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$ API Ref.Price (USD/KG) : 121Xls

USFDA APPLICATION NUMBER - 21163 / DOSAGE - SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALPHA-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
(ALPHA-TOCOPHEROL - UNII:H4N855PNZ1)
ALPHA-TOCOPHEROL ACETATE10[iU] in 10
ASCORBIC ACID(UNII: PQ6CK8PD0R)
(ASCORBIC ACID - UNII:PQ6CK8PD0R)
ASCORBIC ACID200mg in 10
BIOTIN(UNII: 6SO6U10H04)
(BIOTIN - UNII:6SO6U10H04)
BIOTIN60ug in 10
CHOLECALCIFEROL(UNII: 1C6V77QF41)
(CHOLECALCIFEROL - UNII:1C6V77QF41)
CHOLECALCIFEROL200[iU] in 10
CYANOCOBALAMIN(UNII: P6YC3EG204)
(CYANOCOBALAMIN - UNII:P6YC3EG204)
CYANOCOBALAMIN5ug in 10
DEXPANTHENOL(UNII: 1O6C93RI7Z)
(DEXPANTHENOL - UNII:1O6C93RI7Z)
DEXPANTHENOL15mg in 10
FOLIC ACID(UNII: 935E97BOY8)
(FOLIC ACID - UNII:935E97BOY8)
FOLIC ACID600ug in 10
NIACINAMIDE(UNII: 25X51I8RD4)
(NIACINAMIDE - UNII:25X51I8RD4)
NIACINAMIDE40mg in 10
PHYTONADIONE(UNII: A034SE7857)
(PHYTONADIONE - UNII:A034SE7857)
PHYTONADIONE150ug in 10
PYRIDOXINE HYDROCHLORIDE(UNII: 68Y4CF58BV)
(PYRIDOXINE - UNII:KV2JZ1BI6Z)
PYRIDOXINE HYDROCHLORIDE6mg in 10
RIBOFLAVIN 5'-PHOSPHATE SODIUM(UNII: 20RD1DZH99)
(RIBOFLAVIN - UNII:TLM2976OFR)
RIBOFLAVIN3.6mg in 10
THIAMINE HYDROCHLORIDE(UNII: M572600E5P)
(THIAMINE - UNII:X66NSO3N35)
THIAMINE6mg in 10
VITAMIN A PALMITATE(UNII: 1D1K0N0VVC)
(VITAMIN A - UNII:81G40H8B0T)
VITAMIN A3300[iU] in 10

Inactive Ingredients

Ingredient Name
Sandoz Canada Inc
ANHYDROUS CITRIC ACID(XF417D3PSL)
HYDROCHLORIC ACID(QTT17582CB)
POLYSORBATE 80(6OZP39ZG8H)
PROPYLENE GLYCOL(6DC9Q167V3)
SODIUM CITRATE(1Q73Q2JULR)
SODIUM HYDROXIDE(55X04QC32I)