Treats herpes zoster (shingles). ANDA 75090, held by Regcon Holdings. Acyclovir.
As of Nov 13, 2026, ANDA 75090 (Acyclovir), held by Regcon Holdings, was first approved by FDA on Jan 26, 1999, with 4 approved supplements and 0 published complete response letters.
INDICATIONS & USAGE Herpes Zoster Infections: acyclovir is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: acyclovir is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: acyclovir is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jan 26, 1999 | Original application | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG · capsule;oral | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Apr 8, 2016 | Supplement 11Labeling · Standard review | Approved | None posted |
| Feb 6, 2006 | Supplement 7Labeling | Approved | None posted |
| Feb 6, 2006 | Supplement 6Labeling | Approved | None posted |
| Feb 4, 2003 | Supplement 3Labeling | Approved | None posted |
| Jan 26, 1999 | Original application | Approved |
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
