ANDA 203701, held by Eugia Pharma. Acyclovir Sodium.
As of Nov 14, 2026, ANDA 203701 (Acyclovir Sodium), held by Eugia Pharma, was first approved by FDA on Oct 11, 2013, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Simplex Infections in Immunocompromised Patients Acyclovir Sodium 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 Sodium Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immuno-competent patients. Herpes Simplex Encephalitis Acyclovir Sodium Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir Sodium Injection is indicated for the treatment of neonatal herpes infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Oct 11, 2013 | 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
