ANDA 206633, held by Fougera Pharms Inc. Acyclovir.
As of Nov 13, 2026, ANDA 206633 (Acyclovir), held by Fougera Pharms Inc, was first approved by FDA on May 11, 2016, with 1 approved supplement and 0 published complete response letters.
| Date | Submission | Status | Documents |
|---|---|---|---|
| May 11, 2016 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir5% ยท ointment;topical | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 28, 2017 | Supplement 1Manufacturing | Approved | None posted |
| May 11, 2016 | Original application | Approved | None posted |
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
