Treats herpes zoster (shingles). ANDA 215669, held by Hetero Labs Ltd Iii. Acyclovir.
As of Nov 13, 2026, ANDA 215669 (Acyclovir), held by Hetero Labs Ltd Iii, was first approved by FDA on Jul 1, 2022, with 1 approved supplement and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Zoster Infections: Acyclovir oral suspension is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir oral suspension is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir oral suspension is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2022 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG/5ML · suspension;oral | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 1, 2026 | Supplement 6Labeling · Standard review | Approved | None posted |
| Jul 1, 2022 | 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
