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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-three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

Summary for NDA: 019661

Tradename:
CYTOVENE
Applicant:
Roche Palo
Ingredient:
ganciclovir sodium
Patents:0
Therapeutic Class:Antivirals
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 0004-6940-03 25 VIAL in 1 CARTON (0004-6940-03) > 10 mL in 1 VIAL
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

Summary for product number 001

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

Expired Orange Book Patents for NDA: 019661

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 19894,355,032► subscribe
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 19894,507,305► subscribe
Roche Palo
CYTOVENE
ganciclovir sodium
INJECTABLE;INJECTION019661-001Jun 23, 19894,423,050► subscribe
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