ANDA 206535, held by Zydus Pharms. Acyclovir Sodium.
As of Nov 14, 2026, ANDA 206535 (Acyclovir Sodium), held by Zydus Pharms, was first approved by FDA on Aug 31, 2018, with 1 approved supplement 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 immunocompetent 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 neonates and infants with herpes simplex infections.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Aug 31, 2018 | Original application | Approved | None posted |
| Product | Active ingredient | Marketing |
|---|---|---|
| Acyclovir SodiumEQ 50MG BASE/ML · injectable;injection | Acyclovir Sodium | Rx |
| Aug 23, 2021 | Supplement 4Labeling · Standard review | Approved | None posted |
| Aug 31, 2018 | Original application | Approved | None posted |
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
