ACYCLOVIR SODIUM
Details
- Status
- Prescription
- First Approved
- 1997-04-22
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
ACYCLOVIR SODIUM Approval History
What ACYCLOVIR SODIUM Treats
5 indicationsACYCLOVIR SODIUM is approved for 5 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Herpes Simplex Infections
- Herpes Genitalis
- Herpes Simplex Encephalitis
- Neonatal Herpes Simplex Virus Infection
- Varicella-Zoster
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ACYCLOVIR SODIUM FDA Label Details
ProIndications & 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 indica...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.