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Generated: November 12, 2018

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Details for New Drug Application (NDA): 019661

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NDA 019661 describes CYTOVENE, which is a drug marketed by Roche Palo and is included in two NDAs. It is available from one supplier. Additional details are available on the CYTOVENE profile page.

The generic ingredient in CYTOVENE is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 019661
Tradename:CYTOVENE
Applicant:Roche Palo
Ingredient:ganciclovir sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 019661
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 019661
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661 NDA Genentech, Inc. 0004-6940 0004-6940-04 5 VIAL in 1 CARTON (0004-6940-04) > 10 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 500MG BASE/VIAL
Approval Date:Jun 23, 1989TE:APRLD:Yes

Expired US Patents for NDA 019661

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ➤ Sign Up ➤ Sign Up
Roche Palo CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ➤ Sign Up ➤ Sign Up
Roche Palo CYTOVENE ganciclovir sodium INJECTABLE;INJECTION 019661-001 Jun 23, 1989 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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