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FDA Approval

Dialyvite

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

FDA Approval Summary

Company
Effective Date
December 29, 2015
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin C(100 mg in 1 1)
Thiamine(1.5 mg in 1 1)
Riboflavin(1.7 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Biotin(300 ug in 1 1)
Pyridoxine(10 mg in 1 1)
Folic acid(1 mg in 1 1)
Vitamin B12(6 ug in 1 1)
Pantothenic acid(10 mg in 1 1)

Registrants1

Companies and organizations registered with the FDA for this drug approval, including their contact information and regulatory details.

Carilion Materials Management

079239644

Manufacturing Establishments1

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

Carilion Materials Management

Carilion Materials Management

Carilion Materials Management

079239644

Products1

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

Dialyvite

Product Details

NDC Product Code
68151-4402
Route of Administration
ORAL
Effective Date
December 29, 2015
Vitamin CActive
Code: PQ6CK8PD0RClass: ACTIBQuantity: 100 mg in 1 1
ThiamineActive
Code: 8K0I04919XClass: ACTIRQuantity: 1.5 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Code: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 300 ug in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 10 mg in 1 1
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
Code: 8406EY2OQAClass: ACTIBQuantity: 6 ug in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
Cellulose, microcrystallineInactive
Code: OP1R32D61UClass: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
HypromellosesInactive
Code: 3NXW29V3WOClass: IACT
Polyethylene GlycolsInactive
Code: 3WJQ0SDW1AClass: IACT
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
Starch, CornInactive
Code: O8232NY3SJClass: IACT
Calcium StearateInactive
Code: 776XM7047LClass: IACT
CochinealInactive
Code: TZ8Z31B35MClass: IACT
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