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FDA Approval

Quflora Pediatric

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company

CarWin Pharmaceutical Associates, LLC

DUNS: 079217215

Effective Date

January 10, 2024

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Vitamin A acetate(1200 [iU] in 1 1)

Vitamin C(60 mg in 1 1)

Vitamin D3(400 [iU] in 1 1)

Nicotinamide(5 mg in 1 1)

Pyridoxine(1.5 mg in 1 1)

Magnesium oxide(15 mg in 1 1)

Vitamin B12(4 ug in 1 1)

Cupric sulfate(1 mg in 1 1)

Sodium fluoride(0.25 mg in 1 1)

Thiamine(1.2 mg in 1 1)

Riboflavin(1.3 mg in 1 1)

Levomefolic acid(108 ug in 1 1)

Folic acid(100 ug in 1 1)

DL-alpha-Tocopherol(15 [iU] in 1 1)

Products3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Quflora Pediatric

Product Details

NDC Product Code

15370-103

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

Vitamin A acetateActive

Code: 3LE3D9D6OYClass: ACTIMQuantity: 1200 [iU] in 1 1

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 5 mg in 1 1

PyridoxineActive

Code: 68Y4CF58BVClass: ACTIBQuantity: 1.5 mg in 1 1

Magnesium oxideActive

Code: 3A3U0GI71GClass: ACTIBQuantity: 15 mg in 1 1

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 4 ug in 1 1

Cupric sulfateActive

Code: LRX7AJ16DTClass: ACTIMQuantity: 1 mg in 1 1

Sodium fluorideActive

Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.25 mg in 1 1

GRAPEInactive

Code: 6X543N684KClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 1 1

RiboflavinActive

Code: TLM2976OFRClass: ACTIBQuantity: 1.3 mg in 1 1

Levomefolic acidActive

Code: 8S95DH25XCClass: ACTIBQuantity: 108 ug in 1 1

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 100 ug in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

DL-alpha-TocopherolActive

Code: 7QWA1RIO01Class: ACTIBQuantity: 15 [iU] in 1 1

Quflora Pediatric

Product Details

NDC Product Code

15370-105

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

Vitamin A acetateActive

Code: 3LE3D9D6OYClass: ACTIMQuantity: 1200 [iU] in 1 1

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1

RiboflavinActive

Code: TLM2976OFRClass: ACTIBQuantity: 1.3 mg in 1 1

Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 1 1

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 5 mg in 1 1

Cupric sulfateActive

Code: LRX7AJ16DTClass: ACTIMQuantity: 1 mg in 1 1

Levomefolic acidActive

Code: 8S95DH25XCClass: ACTIBQuantity: 108 ug in 1 1

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 4 ug in 1 1

PyridoxineActive

Code: 68Y4CF58BVClass: ACTIBQuantity: 1.5 mg in 1 1

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 100 ug in 1 1

Magnesium oxideActive

Code: 3A3U0GI71GClass: ACTIBQuantity: 15 mg in 1 1

Sodium fluorideActive

Code: 8ZYQ1474W7Class: ACTIMQuantity: 1 mg in 1 1

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

GRAPEInactive

Code: 6X543N684KClass: IACT

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

DL-alpha-TocopherolActive

Code: 7QWA1RIO01Class: ACTIBQuantity: 15 [iU] in 1 1

Quflora Pediatric

Product Details

NDC Product Code

15370-104

Route of Administration

ORAL

Effective Date

January 10, 2024

Ingredients

Vitamin D3Active

Code: 1C6V77QF41Class: ACTIBQuantity: 400 [iU] in 1 1

Vitamin CActive

Code: PQ6CK8PD0RClass: ACTIBQuantity: 60 mg in 1 1

Vitamin A acetateActive

Code: 3LE3D9D6OYClass: ACTIMQuantity: 1200 [iU] in 1 1

RiboflavinActive

Code: TLM2976OFRClass: ACTIBQuantity: 1.3 mg in 1 1

Code: M572600E5PClass: ACTIRQuantity: 1.2 mg in 1 1

NicotinamideActive

Code: 25X51I8RD4Class: ACTIBQuantity: 5 mg in 1 1

PyridoxineActive

Code: 68Y4CF58BVClass: ACTIBQuantity: 1.5 mg in 1 1

Vitamin B12Active

Code: P6YC3EG204Class: ACTIBQuantity: 4 ug in 1 1

Cupric sulfateActive

Code: LRX7AJ16DTClass: ACTIMQuantity: 1 mg in 1 1

Folic acidActive

Code: 935E97BOY8Class: ACTIBQuantity: 100 ug in 1 1

Sodium fluorideActive

Code: 8ZYQ1474W7Class: ACTIMQuantity: 0.5 mg in 1 1

CITRIC ACID MONOHYDRATEInactive

Code: 2968PHW8QPClass: IACT

SILICON DIOXIDEInactive

Code: ETJ7Z6XBU4Class: IACT

GRAPEInactive

Code: 6X543N684KClass: IACT

SUCRALOSEInactive

Code: 96K6UQ3ZD4Class: IACT

MICROCRYSTALLINE CELLULOSEInactive

Code: OP1R32D61UClass: IACT

STEARIC ACIDInactive

Code: 4ELV7Z65APClass: IACT

Levomefolic acidActive

Code: 8S95DH25XCClass: ACTIBQuantity: 108 ug in 1 1

Magnesium oxideActive

Code: 3A3U0GI71GClass: ACTIBQuantity: 15 mg in 1 1

MAGNESIUM STEARATEInactive

Code: 70097M6I30Class: IACT

SUCROSEInactive

Code: C151H8M554Class: IACT

DL-alpha-TocopherolActive

Code: 7QWA1RIO01Class: ACTIBQuantity: 15 [iU] in 1 1

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