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FDA Approval

Vistide

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

FDA Approval Summary

Company
Gilead Sciences, Inc.
DUNS: 185049848
Effective Date
September 24, 2013
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Cidofovir(75 mg in 1 mL)

Products1

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

Vistide

Product Details

NDC Product Code
61958-0101
Application Number
NDA020638
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
September 24, 2013
CidofovirActive
Code: JIL713Q00NClass: ACTIMQuantity: 75 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
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