Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 020961
Company: NOVARTIS

Products on NDA 020961

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VITRAVENE PRESERVATIVE FREE	FOMIVIRSEN SODIUM	6.6MG/ML	INJECTABLE;INJECTION	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 020961

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
08/26/1998	ORIG-1	Approval	Type 1 - New Molecular Entity	PRIORITY	Label (PDF) Letter (PDF) Review		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20961lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/20961ltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/nda/98/20961_Vitravene.cfm

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
04/27/2001	SUPPL-4	Manufacturing (CMC)-Control		Label is not available on this site.
07/31/2000	SUPPL-3	Manufacturing (CMC)-Control		Label is not available on this site.
02/22/1999	SUPPL-1	Manufacturing (CMC)		Label is not available on this site.

Labels for NDA 020961

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
08/26/1998	ORIG-1	Approval	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/1998/20961lbl.pdf