NDA 20705, held by Viiv Hlthcare. Delavirdine Mesylate.
As of Nov 13, 2026, NDA 20705 (Rescriptor), held by Viiv Hlthcare, was first approved by FDA on Apr 4, 1997, with 8 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 16, 2001 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Apr 4, 1997 | Original applicationNew molecular entity · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Rescriptor100MG · tablet;oral | Delavirdine Mesylate | DiscontinuedReference drug |
| Rescriptor200MG · tablet;oral | Delavirdine Mesylate | DiscontinuedReference drug |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 10, 2012 | Supplement 18Labeling | Approved | |
| Apr 7, 2006 | Supplement 10Labeling · Standard review | Approved | |
| Mar 14, 2002 | Supplement 9Labeling · Standard review | Approved | |
| May 16, 2001 | Supplement 8Efficacy (new indication or use) · Standard review | Approved | |
| Aug 16, 1999 | Supplement 4Labeling · Standard review | Approved | |
| Jul 14, 1999 | Supplement 3Manufacturing · Priority review | Approved | |
| Oct 23, 1998 | Supplement 2Manufacturing · Priority review | Approved | |
| Feb 11, 1998 | Supplement 1Labeling · Standard review | Approved | None posted |
| Apr 4, 1997 | Original applicationNew molecular entity · Priority review | Approved | None posted |
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
