Treats herpes zoster (shingles). ANDA 74738, held by Actavis Mid Atlantic. Acyclovir.
As of Nov 13, 2026, ANDA 74738 (Acyclovir), held by Actavis Mid Atlantic, was first approved by FDA on Apr 28, 1997, with 10 approved supplements and 0 published complete response letters.
INDICATIONS AND 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 |
|---|---|---|---|
| Apr 28, 1997 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG/5ML · suspension;oral | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2026 | Supplement 38Labeling · Standard review | Approved | None posted |
| Jun 10, 2009 | Supplement 28Labeling | Approved | None posted |
| Jan 24, 2005 | Supplement 12Labeling | Approved | None posted |
| Sep 18, 2002 | Supplement 7Labeling | Approved | None posted |
| Feb 22, 2002 | Supplement 6Manufacturing | Approved | None posted |
| Jun 13, 2001 | Supplement 5Labeling | Approved | None posted |
| Jan 16, 2001 | Supplement 3Manufacturing | Approved | None posted |
| Nov 16, 2000 | Supplement 4Labeling | Approved | None posted |
| Jul 6, 1998 | Supplement 2Labeling | Approved | None posted |
| Mar 26, 1998 | Supplement 1Labeling | Approved | None posted |
| Apr 28, 1997 | 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
