Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020460
Company: ROCHE PALO

Products on NDA 020460

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
CYTOVENE	GANCICLOVIR	250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No
CYTOVENE	GANCICLOVIR	500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**	CAPSULE;ORAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020460

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
12/22/1994	ORIG-1	Approval	Type 3 - New Dosage Form	PRIORITY		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/13/2002	SUPPL-12	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
10/17/2000	SUPPL-11	Manufacturing (CMC)		Label is not available on this site.
12/01/2000	SUPPL-10	Labeling		Label is not available on this site.
10/21/1998	SUPPL-9	Manufacturing (CMC)		Label is not available on this site.
12/12/1997	SUPPL-8	Efficacy-New Dosing Regimen	Review (PDF)	Label is not available on this site.	https://www.accessdata.fda.gov/drugsatfda_docs/nda/97/20460.pdf
05/30/1997	SUPPL-7	Manufacturing (CMC)-Packaging		Label is not available on this site.
11/27/1996	SUPPL-6	Efficacy-New Indication		Label is not available on this site.
10/27/1995	SUPPL-5	Efficacy-New Indication		Label is not available on this site.
12/30/1997	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
03/01/1995	SUPPL-3	Labeling		Label is not available on this site.
07/20/1995	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.