Quflora Pediatric Drops
Quflora 0.25 mg/mL F* Pediatric Fluoride Drops
Approved
Approval ID
60375632-baf4-4f6d-9a8d-38604b8ad860
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 3, 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 ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code15370-100
Product Classification
G
Generic Name
VITAMIN A ACETATE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLIC ACID, CYANOCOBALAMIN, MAGNESIUM OXIDE, CUPRIC SULFATE, and SODIUM FLUORIDE
Product Specifications
Route of AdministrationORAL
Effective DateAugust 3, 2017
FDA Product Classification
INGREDIENTS (19)
VITAMIN A ACETATEActive
Quantity: 1000 [iU] in 1 mL
Code: 3LE3D9D6OY
Classification: ACTIM
ASCORBIC ACIDActive
Quantity: 35 mg in 1 mL
Code: PQ6CK8PD0R
Classification: ACTIB
CHOLECALCIFEROLActive
Quantity: 400 [iU] in 1 mL
Code: 1C6V77QF41
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
NIACINAMIDEActive
Quantity: 0.8 mg in 1 mL
Code: 25X51I8RD4
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 0.4 mg in 1 mL
Code: 68Y4CF58BV
Classification: ACTIB
LEVOMEFOLIC ACIDActive
Quantity: 35 ug in 1 mL
Code: 8S95DH25XC
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 2 ug in 1 mL
Code: P6YC3EG204
Classification: ACTIB
MAGNESIUM OXIDEActive
Quantity: 10 mg in 1 mL
Code: 3A3U0GI71G
Classification: ACTIB
CUPRIC SULFATEActive
Quantity: 1 mg in 1 mL
Code: LRX7AJ16DT
Classification: ACTIM
SODIUM FLUORIDEActive
Quantity: 0.25 mg in 1 mL
Code: 8ZYQ1474W7
Classification: ACTIM
CARRAGEENANInactive
Code: 5C69YCD2YJ
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
GRAPEInactive
Code: 6X543N684K
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATE, D-Active
Quantity: 5 [iU] in 1 mL
Code: A7E6112E4N
Classification: ACTIM