Treats recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents…. ANDA 206770, held by Zydus Lifesciences. Acyclovir.
As of Nov 13, 2026, ANDA 206770 (Acyclovir), held by Zydus Lifesciences, was first approved by FDA on Feb 28, 2023, with 0 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 |
|---|---|---|---|
| Feb 28, 2023 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% · cream;topical | Acyclovir | Rx |
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
