Hivid

NDA 20199, held by Roche. Zalcitabine.

As of Nov 13, 2026, NDA 20199 (Hivid), held by Roche, was first approved by FDA on Jun 19, 1992, with 17 approved supplements and 0 published complete response letters.

First approved: Jun 19, 1992
Review: Priority
Supplements approved: 17
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 18 submissions below

Date	Submission	Status	Documents
Jun 26, 1996	Supplement 7Efficacy (new indication or use) · Priority review	Approved	None posted
Aug 5, 1994	Supplement 3Efficacy (new indication or use)	Approved	None posted
Jun 19, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Products

2 strengths and forms

Product	Active ingredient	Marketing
Hivid0.375MG · tablet;oral	Zalcitabine	Discontinued
Hivid0.75MG · tablet;oral	Zalcitabine	Discontinued

All 18 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Sep 12, 2002	Supplement 16Labeling · Standard review	Approved	Letter Label
Aug 14, 2002	Supplement 15Labeling · Standard review	Approved	Letter Label
Aug 2, 2002	Supplement 17Manufacturing	Approved	None posted
Jul 3, 2002	Supplement 14Labeling · Standard review	Approved	Letter Label
Apr 19, 2000	Supplement 12Labeling · Standard review	Approved	None posted
Jun 1, 1999	Supplement 13Labeling · Standard review	Approved	None posted
Aug 28, 1998	Supplement 11Labeling · Standard review	Approved	None posted
Mar 4, 1998	Supplement 10Labeling · Standard review	Approved	None posted
Oct 15, 1997	Supplement 9Manufacturing	Approved	None posted
Oct 4, 1996	Supplement 8Labeling · Standard review	Approved	None posted
Jun 26, 1996	Supplement 7Efficacy (new indication or use) · Priority review	Approved	None posted
Mar 4, 1996	Supplement 6Manufacturing	Approved	None posted
Oct 7, 1994	Supplement 4Labeling · Standard review	Approved	None posted
Oct 7, 1994	Supplement 2Labeling · Standard review	Approved	None posted
Aug 5, 1994	Supplement 3Efficacy (new indication or use)	Approved	None posted
Jul 8, 1994	Supplement 5Manufacturing	Approved	None posted
Apr 13, 1994	Supplement 1Manufacturing	Approved	None posted
Jun 19, 1992	Original applicationNew molecular entity · Priority review	Approved	None posted

Identifiers

Application: NDA 20199
Drugs@FDA: Overview at FDA
Company: Roche

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