Vira-A

NDA 50486, held by Parkedale. Vidarabine.

As of Nov 14, 2026, NDA 50486 (Vira-A), held by Parkedale, was first approved by FDA on Nov 26, 1976, with 15 approved supplements and 0 published complete response letters.

First approved: Nov 26, 1976
Review: Priority
Supplements approved: 15
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 16 submissions below


Dec 22, 1976	Supplement 1Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 26, 1976	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Vira-A3% · ointment;ophthalmic	Vidarabine	Discontinued

All 16 submissions, including labeling and manufacturing supplements


Jul 26, 1999	Supplement 17Manufacturing · Priority review	Approved	None posted
Sep 28, 1998	Supplement 16Manufacturing · Priority review	Approved	None posted
Aug 4, 1997	Supplement 15Manufacturing · Priority review	Approved	None posted
Aug 4, 1997	Supplement 14Labeling · Priority review	Approved	None posted
Aug 4, 1997	Supplement 11Labeling · Priority review	Approved	None posted
Aug 27, 1996	Supplement 13Labeling · Priority review	Approved	None posted
Apr 29, 1981	Supplement 10Labeling · Priority review	Approved	None posted
Jan 22, 1980	Supplement 8Labeling · Priority review	Approved	None posted
Dec 20, 1979	Supplement 7Manufacturing · Priority review	Approved	None posted
Jun 5, 1978	Supplement 6Manufacturing · Priority review	Approved	None posted
Mar 15, 1978	Supplement 5Labeling · Priority review	Approved	None posted
Dec 12, 1977	Supplement 12Labeling · Priority review	Approved	None posted
Nov 15, 1977	Supplement 3Labeling · Priority review	Approved	None posted
Jul 1, 1977	Supplement 2Manufacturing · Priority review	Approved	None posted
Dec 22, 1976	Supplement 1Efficacy (new indication or use) · Priority review	Approved	None posted
Nov 26, 1976	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 50486
Drugs@FDA: Overview at FDA
Company: Parkedale Pharmaceuticals

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters