NDA 20550, held by Glaxosmithkline. Valacyclovir Hydrochloride.
As of Nov 13, 2026, NDA 20550 (Valtrex), held by Glaxosmithkline, was first approved by FDA on Dec 15, 1995, with 20 approved supplements and 0 published complete response letters.
| Aug 29, 2003 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Apr 1, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Sep 9, 2002 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jun 25, 2001 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Sep 26, 1997 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Oct 4, 1996 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | None posted |
| Dec 15, 1995 | Original applicationTYPE 6 · Priority review | Approved | None posted |
| ValtrexEQ 500MG BASE · tablet; oral | Valacyclovir Hydrochloride | Rx |
| ValtrexEQ 1GM BASE · tablet; oral | Valacyclovir Hydrochloride | Rx |
| Aug 29, 2003 | Supplement 19Efficacy (new indication or use) · Standard review | Approved | |
| Aug 8, 2003 | Supplement 21Labeling · Standard review | Approved | |
| Apr 1, 2003 | Supplement 5Efficacy (new indication or use) · Standard review | Approved | |
| Dec 18, 2002 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Sep 9, 2002 | Supplement 16Efficacy (new indication or use) · Standard review | Approved | |
| Jul 3, 2002 | Supplement 17Manufacturing · Priority review | Approved | None posted |
| Mar 14, 2002 | Supplement 15Manufacturing · Priority review | Approved | None posted |
| Jun 25, 2001 | Supplement 13Labeling · Standard review | Approved | |
| Jun 25, 2001 | Supplement 12Efficacy (new indication or use) · Standard review | Approved | |
| Jun 25, 2001 | Supplement 10Labeling · Standard review | Approved | |
| Jun 1, 2001 | Supplement 14Manufacturing · Priority review | Approved | None posted |
| Apr 20, 2000 | Supplement 11Labeling · Standard review | Approved | None posted |
| Apr 20, 2000 | Supplement 9Labeling · Standard review | Approved | None posted |
| Jul 22, 1999 | Supplement 8Manufacturing · Priority review | Approved | None posted |
| Feb 2, 1999 | Supplement 7Manufacturing · Priority review | Approved | None posted |
| Nov 25, 1998 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Sep 26, 1997 | Supplement 3Efficacy (new indication or use) · Standard review | Approved | |
| Apr 30, 1997 | Supplement 4Labeling · Standard review | Approved | None posted |
| Oct 18, 1996 | Supplement 2Labeling · Standard review | Approved | None posted |
| Oct 4, 1996 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | None posted |
| Dec 15, 1995 | Original applicationTYPE 6 · 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
