NDA 18828, held by Pharmobedient. Acyclovir.
As of Nov 13, 2026, NDA 18828 (Zovirax), held by Pharmobedient, was first approved by FDA on Jan 25, 1985, with 27 approved supplements and 0 published complete response letters.
| Feb 26, 1992 | Supplement 10Efficacy (new indication or use) | Approved | |
| Apr 20, 1990 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Dec 22, 1989 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Jan 25, 1985 | Original applicationNew dosage form · Priority review | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zovirax200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** · capsule;oral | Acyclovir | DiscontinuedReference drug |
| Nov 12, 2025 | Supplement 33Labeling · Standard review | Approved | |
| Aug 8, 2008 | Supplement 31Labeling · Standard review | Approved | |
| Dec 9, 2005 | Supplement 30Labeling · Standard review | Approved | |
| May 19, 2004 | Supplement 29Labeling · Standard review | Approved | |
| Nov 14, 2001 | Supplement 26Labeling · Standard review | Approved | |
| Nov 14, 2001 | Supplement 27Labeling · Standard review | Approved | |
| Jul 12, 2000 | Supplement 25Manufacturing · Priority review | Approved | None posted |
| Mar 15, 2000 | Supplement 22Labeling · Standard review | Approved | None posted |
| Mar 15, 2000 | Supplement 24Labeling · Standard review | Approved | None posted |
| Feb 18, 1999 | Supplement 23Manufacturing · Priority review | Approved | None posted |
| Nov 4, 1997 | Supplement 21Manufacturing · Priority review | Approved | None posted |
| May 29, 1997 | Supplement 20Labeling · Standard review | Approved | None posted |
| Jan 8, 1997 | Supplement 19Labeling · Standard review | Approved | None posted |
| Oct 29, 1996 | Supplement 18Manufacturing · Priority review | Approved | None posted |
| Apr 12, 1995 | Supplement 17Labeling · Standard review | Approved | None posted |
| Apr 14, 1994 | Supplement 14Labeling · Standard review | Approved | None posted |
| Nov 9, 1993 | Supplement 13Manufacturing · Priority review | Approved | None posted |
| Apr 22, 1993 | Supplement 5Labeling | Approved | None posted |
| Apr 22, 1993 | Supplement 12Labeling | Approved | None posted |
| Feb 26, 1992 | Supplement 10Efficacy (new indication or use) | Approved | |
| Apr 30, 1991 | Supplement 9Labeling | Approved | None posted |
| Apr 20, 1990 | Supplement 7Efficacy (new indication or use) | Approved | None posted |
| Dec 22, 1989 | Supplement 1Efficacy (new indication or use) | Approved | None posted |
| Oct 24, 1988 | Supplement 6Manufacturing · Priority review | Approved | None posted |
| Oct 24, 1988 | Supplement 8Labeling | Approved | None posted |
| Oct 29, 1987 | Supplement 3Labeling | Approved | None posted |
| Dec 2, 1986 | Supplement 2Labeling | Approved | None posted |
| Jan 25, 1985 | Original applicationNew dosage form · 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
