Treats recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents…. NDA 21478, held by Bausch. Acyclovir.
As of Nov 14, 2026, NDA 21478 (Zovirax), held by Bausch, was first approved by FDA on Dec 30, 2002, with 4 approved supplements and 0 published complete response letters.
Acyclovir Cream is a herpes simplex virus (HSV) deoxynucleoside analogue DNA polymerase inhibitor indicated for the treatment of recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 30, 2002 | Original applicationNew dosage form · Standard review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Zovirax5% · cream;topical | Acyclovir | RxReference drug |
| Dec 23, 2020 | Supplement 10Labeling · Standard review | Approved | |
| Feb 3, 2015 | Supplement 8Manufacturing · Standard review | Approved | |
| Apr 1, 2014 | Supplement 7Labeling · Standard review | Approved | |
| Jan 23, 2004 | Supplement 3Manufacturing · Standard review | Approved | |
| Dec 30, 2002 | Original applicationNew dosage form · Standard review | Approved |
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
