Treats herpes zoster (shingles). ANDA 75211, held by Aurobindo Pharma USA. Acyclovir.
As of Nov 14, 2026, ANDA 75211 (Acyclovir), held by Aurobindo Pharma USA, was first approved by FDA on Sep 28, 1998, with 7 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir tablets are indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir tablets are indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir tablets are indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Sep 28, 1998 | Original application | Approved |
| Jun 5, 2026 | Supplement 16Labeling · Standard review | Approved | None posted |
| Dec 7, 2009 | Supplement 9Labeling | Approved | None posted |
| Oct 21, 2004 | Supplement 6Labeling | Approved | None posted |
| Jul 31, 2002 | Supplement 4Labeling | Approved | None posted |
| Mar 13, 2002 | Supplement 3Labeling | Approved | None posted |
| Apr 18, 2001 | Supplement 2Manufacturing | Approved | None posted |
| Jul 23, 1999 | Supplement 1Manufacturing | Approved | None posted |
| Sep 28, 1998 | Original application | 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
