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FDA Approval

Prenara

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

FDA Approval Summary

Effective Date
March 3, 2020
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin A(1000 [iU] in 1 1)
Vitamin D3(750 [iU] in 1 1)
Vitamin C(100 mg in 1 1)
Thiamine(1.8 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Riboflavin(1.7 mg in 1 1)
Pyridoxine(2.5 mg in 1 1)
Folic acid(1 mg in 1 1)
Vitamin B12(0.5 mg in 1 1)
Iopromide(0.15 mg in 1 1)
Calcium(100 mg in 1 1)
Magnesium(15 mg in 1 1)
Zinc(20 mg in 1 1)
Copper(2 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

Sterling-Knight Pharmaceuticals, LLC

Sterling-Knight Pharmaceuticals, LLC

079556942

Products1

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

Prenara

Product Details

NDC Product Code
69336-352
Route of Administration
ORAL
Effective Date
March 9, 2020
Vitamin AActive
Code: 81G40H8B0TClass: ACTIBQuantity: 1000 [iU] in 1 1
Code: 9VU1KI44GPClass: ACTIBQuantity: 750 [iU] in 1 1
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 100 mg in 1 1
ThiamineActive
Code: X66NSO3N35Class: ACTIBQuantity: 1.8 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 2.5 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 0.5 mg in 1 1
IopromideActive
Code: 9679TC07X4Class: ACTIBQuantity: 0.15 mg in 1 1
CalciumActive
Code: SY7Q814VUPClass: ACTIBQuantity: 100 mg in 1 1
MagnesiumActive
Code: I38ZP9992AClass: ACTIBQuantity: 15 mg in 1 1
ZincActive
Code: J41CSQ7QDSClass: ACTIBQuantity: 20 mg in 1 1
CopperActive
Code: 789U1901C5Class: ACTIBQuantity: 2 mg in 1 1
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