Quflora FE Pediatric Drops
Quflora FE Pediatric Liquid Drops
Approved
Approval ID
feb95882-69f1-4f30-91aa-505f45f3ab3f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 19, 2017
Manufacturers
FDA
Carwin Pharmaceutical Associates, LLC
DUNS: 079217215
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, FERROUS SULFATE, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-102
Product Classification
G
Generic Name
VITAMIN A PALMITATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PANTOTHENIC ACID, PYRIDOXINE HYDROCHLORIDE, BIOTIN, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, FERROUS SULFATE, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateApril 21, 2017
FDA Product Classification
INGREDIENTS (21)
VITAMIN A PALMITATEActive
Quantity: 1500 [iU] in 1 mL
Code: 1D1K0N0VVC
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 36 mg in 1 mL
Code: PQ6CK8PD0R
Classification: ACTIB
THIAMINE HYDROCHLORIDEActive
Quantity: 0.5 mg in 1 mL
Code: M572600E5P
Classification: ACTIR
RIBOFLAVINActive
Quantity: 0.6 mg in 1 mL
Code: TLM2976OFR
Classification: ACTIB
PANTOTHENIC ACIDActive
Quantity: 1 mg in 1 mL
Code: 19F5HK2737
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 mL
Code: 68Y4CF58BV
Classification: ACTIB
LEVOMEFOLATE GLUCOSAMINEActive
Quantity: 37.5 ug in 1 mL
Code: Q65PL71Q1A
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 mL
Code: 1C6V77QF41
Classification: ACTIB
NIACINAMIDEActive
Quantity: 4 mg in 1 mL
Code: 25X51I8RD4
Classification: ACTIB
BIOTINActive
Quantity: 3 ug in 1 mL
Code: 6SO6U10H04
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 2 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
FERROUS SULFATEActive
Quantity: 9.5 mg in 1 mL
Code: 39R4TAN1VT
Classification: ACTIM
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLENEInactive
Code: AUG1H506LY
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, D-Active
Quantity: 5 [iU] in 1 mL
Code: A7E6112E4N
Classification: ACTIM