Details for New Drug Application (NDA): 020460

NDA 020460 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 020460

Tradename:	CYTOVENE
Applicant:	Roche Palo
Ingredient:	ganciclovir
Patents:	0

Medical Subject Heading (MeSH) Categories for 020460

Antiviral Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Dec 22, 1994	TE:		RLD:	Yes

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	CAPSULE;ORAL			Strength	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:	Dec 12, 1997	TE:		RLD:	Yes

Expired US Patents for NDA 020460

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994

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