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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
May 11, 2017
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Vitamin C(100 mg in 1 1)
Thiamine(1.5 mg in 1 1)
Nicotinamide(20 mg in 1 1)
Pyridoxine(10 mg in 1 1)
Riboflavin(1.7 mg in 1 1)
Pantothenic acid(10 mg in 1 1)
Biotin(300 ug in 1 1)
Vitamin B12(6 ug in 1 1)
Folic acid(1 mg in 1 1)

Manufacturing Establishments1

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

Atlantic Biologicals Corps

Atlantic Biologicals Corps

047437707

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
17856-0010
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: 25X51I8RD4Class: ACTIBQuantity: 20 mg in 1 1
Code: 68Y4CF58BVClass: ACTIMQuantity: 10 mg in 1 1
Code: TLM2976OFRClass: ACTIBQuantity: 1.7 mg in 1 1
Code: 568ET80C3DClass: ACTIMQuantity: 10 mg in 1 1
Croscarmellose SodiumInactive
Code: M28OL1HH48Class: IACT
BiotinActive
Code: 6SO6U10H04Class: ACTIBQuantity: 300 ug in 1 1
Code: 8406EY2OQAClass: ACTIBQuantity: 6 ug in 1 1
Starch, CornInactive
Code: O8232NY3SJClass: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
Glyceryl MonostearateInactive
Code: 230OU9XXE4Class: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1AClass: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WOClass: IACT
Calcium StearateInactive
Code: 776XM7047LClass: IACT
CochinealInactive
Code: TZ8Z31B35MClass: IACT
Code: 935E97BOY8Class: ACTIBQuantity: 1 mg in 1 1
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