ANDA 205771, held by Hikma. Acyclovir Sodium.
As of Nov 14, 2026, ANDA 205771 (Acyclovir Sodium), held by Hikma, was first approved by FDA on Feb 29, 2016, with 0 approved supplements and 0 published complete response letters.
INDICATIONS AND USAGE Herpes Simplex Infections in Immunocompromised Patients Acyclovir for 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 for Injection is indicated for the treatment of severe initial clinical episodes of herpes genitalis in immunocompetent patients. Herpes Simplex Encephalitis Acyclovir for Injection is indicated for the treatment of herpes simplex encephalitis. Neonatal Herpes Simplex Virus Infection Acyclovir for Injection is indicated for the treatment of neonatal herpes infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 29, 2016 | Original application | Approved |
| Acyclovir SodiumEQ 500MG BASE/VIAL · injectable;injection | Acyclovir Sodium | Discontinued |
| Acyclovir SodiumEQ 1GM BASE/VIAL · injectable;injection | Acyclovir Sodium | Discontinued |
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
