Treats herpes zoster (shingles). ANDA 212252, held by Novitium Pharma. Acyclovir.
As of Nov 13, 2026, ANDA 212252 (Acyclovir), held by Novitium Pharma, was first approved by FDA on Jul 10, 2020, with 1 approved supplement and 0 published complete response letters.
INDICATIONS & USAGE Herpes Zoster Infections: Acyclovir Oral Suspension, USP is indicated for the acute treatment of herpes zoster (shingles). Genital Herpes: Acyclovir Oral Suspension, USP is indicated for the treatment of initial episodes and the management of recurrent episodes of genital herpes. Chickenpox: Acyclovir Oral Suspension, USP is indicated for the treatment of chickenpox (varicella).
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 10, 2020 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir200MG/5ML · suspension;oral | Acyclovir | Rx |
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jul 2, 2026 | Supplement 15Labeling · Standard review | Approved | None posted |
| Jul 10, 2020 | 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
