Drugs@FDA: FDA Approved Drug Products

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New Drug Application (NDA): 020460
Company: ROCHE PALO
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CYTOVENE GANCICLOVIR 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
CYTOVENE GANCICLOVIR 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** CAPSULE;ORAL Discontinued None Yes No
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.

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