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FDA Approval

Corvert

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

FDA Approval Summary

Company
Effective Date
January 25, 2024
Labeling Type
HUMAN PRESCRIPTION DRUG LABEL
Ibutilide(0.1 mg in 1 mL)

Manufacturing Establishments1

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

Pharmacia & Upjohn Company LLC

Pharmacia & Upjohn Company LLC

618054084

Products1

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

Corvert

Product Details

NDC Product Code
0009-3794
Application Number
NDA020491
Marketing Category
NDA (C73594)
Route of Administration
INTRAVENOUS
Effective Date
September 13, 2023
IbutilideActive
Code: 9L5X4M5L6IClass: ACTIBQuantity: 0.1 mg in 1 mL
SODIUM ACETATEInactive
Code: 4550K0SC9BClass: IACTQuantity: 0.189 mg in 1 mL
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACTQuantity: 8.9 mg in 1 mL
HYDROCHLORIC ACIDInactive
Code: QTT17582CBClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
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