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Last Updated: April 16, 2024

Details for New Drug Application (NDA): 019661

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NDA 019661 describes CYTOVENE, which is a drug marketed by Roche Palo and Cheplapharm and is included in two NDAs. 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:	Cheplapharm
Ingredient:	ganciclovir sodium
Patents:	0
Formulation / Manufacturing:	see details

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Approval Date:	Jun 23, 1989	TE:		RLD:	Yes

Expired US Patents for NDA 019661

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	⤷ Try a Trial	⤷ Try a Trial
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	⤷ Try a Trial	⤷ Try a Trial
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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