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FDA Approval

NewVite

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

FDA Approval Summary

Company
Trivia Pharmaceuticals, LLC
DUNS: 119353862
Effective Date
June 23, 2025
Labeling Type
Dietary Supplement
Vitamin C(90 mg in 1 1)
Biotin(30 ug in 1 1)
Vitamin D3(10 ug in 1 1)
Vitamin B12(9 ug in 1 1)
Folic acid(400 ug in 1 1)
Nicotinamide(20 mg in 1 1)
Pantothenic acid(10 mg in 1 1)
Pyridoxine(3 mg in 1 1)
Vitamin A acetate(1500 ug in 1 1)
Riboflavin(3.4 mg in 1 1)
Thiamine(3 mg in 1 1)

Products1

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

NewVite

Product Details

NDC Product Code
84781-012
Route of Administration
ORAL
Effective Date
June 23, 2025
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 90 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 30 ug in 1 1
Code: 1C6V77QF41Class: ACTIBQuantity: 10 ug in 1 1
Code: P6YC3EG204Class: ACTIBQuantity: 9 ug in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 400 ug in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
Code: 68Y4CF58BVClass: ACTIBQuantity: 3 mg in 1 1
Code: 3LE3D9D6OYClass: ACTIMQuantity: 1500 ug in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 3.4 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 3 mg in 1 1
Code: WR1WPI7EW8Class: ACTIMQuantity: 13.5 mg in 1 1

Drug Labeling Information

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label:

NewVite Label

STATEMENT OF IDENTITY SECTION

Description:

NewVite Tablets are supplied as brown, oblong tablets dispensed in plastic bottles of 30 ct.

84781-012-01

Reserved for Professional Recommendation

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician’s supervision. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
Trivia Pharmaceuticals

Gilbert, AZ


DOSAGE & ADMINISTRATION SECTION

Dosage and Administration:

Adults - One caplet daily as a dietary supplement, preferably with a meal, or as recommended by your health professional.


WARNINGS SECTION

Warnings and Precautions:

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

As with any supplement, if you are pregnant, nursing, taking medication, or have a medical condition, ask a health professional before taking this product.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

PRECAUTIONS SECTION

Precautions:

CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

PRECAUTIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

ADVERSE REACTIONS
Allergic sensitizations have been reported following oral administration of folic acid. Consult your physician immediately if adverse side effects occur.

KEEP OUT OF THE REACH OF CHILDREN.

SAFE HANDLING WARNING SECTION

Storage:

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F).


HEALTH CLAIM SECTION

Health Claim Section:

NewVite Tablets

image description

Other ingredients:
microcrystalline cellulose, gelatin, stearic acid, hypromellose, croscarmellose sodium, starch, silicon dioxide, magnesium stearate, dicalcium phosphate, FD&C Red #40 lake, sucrose, mineral oil, polyethylene glycol, titanium dioxide, sodium ascorbate, FD&C Yellow #6 lake, tocopherols, triglycerides, tricalcium phosphate, sodium benzoate, BHT, ascorbyl palmitate, sorbic acid, and talc.


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