NDA 21007, held by Glaxosmithkline. Amprenavir.
As of Nov 13, 2026, NDA 21007 (Agenerase), held by Glaxosmithkline, was first approved by FDA on Apr 15, 1999, with 15 approved supplements and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 5, 2002 | Supplement 10Efficacy (new indication or use) | Approved | |
| May 11, 2001 | Supplement 6Efficacy (new indication or use) | Approved | |
| Apr 15, 1999 | Original applicationNew molecular entity | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Agenerase50MG · capsule;oral | Amprenavir | Discontinued |
| Agenerase150MG · capsule;oral | Amprenavir | Discontinued |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Nov 4, 2005 | Supplement 17Labeling | Approved | |
| Feb 12, 2004 | Supplement 16Labeling | Approved | |
| Oct 2, 2002 | Supplement 15Labeling | Approved | |
| Oct 2, 2002 | Supplement 14Labeling | Approved | |
| Aug 2, 2002 | Supplement 11Labeling | Approved | |
| Feb 5, 2002 | Supplement 13Labeling | Approved | |
| Feb 5, 2002 | Supplement 10Efficacy (new indication or use) | Approved | |
| May 11, 2001 | Supplement 6Efficacy (new indication or use) | Approved | |
| May 9, 2001 | Supplement 9Labeling | Approved | None posted |
| Dec 19, 2000 | Supplement 5Labeling | Approved | None posted |
| Dec 14, 2000 | Supplement 8Manufacturing | Approved | None posted |
| Apr 28, 2000 | Supplement 2Labeling | Approved | None posted |
| Apr 24, 2000 | Supplement 3Labeling | Approved | None posted |
| Dec 22, 1999 | Supplement 4Manufacturing | Approved | None posted |
| Sep 22, 1999 | Supplement 1Labeling | Approved | None posted |
| Apr 15, 1999 | Original applicationNew molecular entity | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed weekly; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
