Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 050486
Company: PARKEDALE

Products on NDA 050486

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
VIRA-A	VIDARABINE	3%	OINTMENT;OPHTHALMIC	Discontinued	None	No	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 050486

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
11/26/1976	ORIG-1	Approval	Type 1 - New Molecular Entity	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
07/26/1999	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
09/28/1998	SUPPL-16	Manufacturing (CMC)-Packaging		Label is not available on this site.
08/04/1997	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
08/04/1997	SUPPL-14	Labeling		Label is not available on this site.
08/27/1996	SUPPL-13	Labeling		Label is not available on this site.
12/12/1977	SUPPL-12	Labeling		Label is not available on this site.
08/04/1997	SUPPL-11	Labeling		Label is not available on this site.
04/29/1981	SUPPL-10	Labeling		Label is not available on this site.
01/22/1980	SUPPL-8	Labeling		Label is not available on this site.
12/20/1979	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
06/05/1978	SUPPL-6	Manufacturing (CMC)		Label is not available on this site.
03/15/1978	SUPPL-5	Labeling		Label is not available on this site.
11/15/1977	SUPPL-3	Labeling		Label is not available on this site.
07/01/1977	SUPPL-2	Manufacturing (CMC)		Label is not available on this site.
12/22/1976	SUPPL-1	Efficacy-New Indication		Label is not available on this site.