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FDA Approval

CIDOFOVIR

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

FDA Approval Summary

Company
Effective Date
April 15, 2021
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.

CIDOFOVIR

Product Details

NDC Product Code
67457-210
Application Number
ANDA201276
Marketing Category
ANDA (C73584)
Route of Administration
INTRAVENOUS
Effective Date
February 25, 2020
CidofovirActive
Code: JIL713Q00NClass: ACTIMQuantity: 75 mg in 1 mL
WATERInactive
Code: 059QF0KO0RClass: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
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