ANDA 215404, held by Fresenius Kabi USA. Acyclovir Sodium.
As of Nov 14, 2026, ANDA 215404 (Acyclovir Sodium), held by Fresenius Kabi USA, was first approved by FDA on Jun 25, 2024, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE: Herpes Simplex Infections in Immunocompromised Patients Acyclovir Injection is indicated for the treatment of initial and recurrent mucosal and cutaneous herpes simplex (HSV-1 and HSV-2) in immunocompromised patients. Initial Episodes of Herpes Genitalis Acyclovir Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immuno-competent patients. Herpes Simplex Encephalitis Acyclovir Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir Injection is indicated for the treatment of neonates and infants with herpes simplex infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Jun 25, 2024 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir SodiumEQ 50MG BASE/ML · injectable;injection | Acyclovir Sodium | Rx |
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
