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Details for New Drug Application (NDA): 020491

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NDA 020491 describes CORVERT, which is a drug marketed by Pharmacia And Upjohn and is included in one NDA. It is available from one supplier. Additional details are available on the CORVERT profile page.

The generic ingredient in CORVERT is ibutilide fumarate. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ibutilide fumarate profile page.

Summary for NDA: 020491

Tradename:
CORVERT
Applicant:
Pharmacia And Upjohn
Ingredient:
ibutilide fumarate
Patents:0
Formulation / Manufacturing:see details

Pharmacology for NDA: 020491

Suppliers and Packaging for NDA: 020491

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CORVERT
ibutilide fumarate
INJECTABLE;INJECTION 020491 NDA Pharmacia and Upjohn Company 0009-3794 0009-3794-44 10 mL in 1 VIAL, SINGLE-DOSE (0009-3794-44)
CORVERT
ibutilide fumarate
INJECTABLE;INJECTION 020491 NDA Pharmacia and Upjohn Company 0009-3794 0009-3794-22 10 mL in 1 VIAL, SINGLE-DOSE (0009-3794-22)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength0.1MG/ML
Approval Date:Dec 28, 1995TE:APRLD:Yes

Expired Orange Book Patents for NDA: 020491

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
CORVERT
ibutilide fumarate
INJECTABLE;INJECTION020491-001Dec 28, 19955,155,268► subscribe
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