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Data updated: Jun 28, 2026

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE (acyclovir sodium) · EUROHLTH INTL SARL

Infectious Disease Approved 1997-12-19

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE is FDA-approved to treat 5 conditions (same as ACYCLOVIR SODIUM).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
28
Years on Market

Details

Status
Discontinued
First Approved
1997-12-19
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

EUROHLTH INTL SARL
Active Ingredient: ACYCLOVIR SODIUM

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE Approval History

1998
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Original
New Indication
New Form
Label Update
4 FDA actions from 1997 to 2000
Apr 2000 SUPPL
Label · Labeling
Dec 1997 ORIGINAL
Update

What ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE Treats

5 indications

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE 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

Same approved indications as ACYCLOVIR SODIUM (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT00855309 results posted IRB00007690 P30CA012197, CCCWFU-98608 Ph 3 completed Acyclovir in Preventing Herpes Simplex Virus Infection in Patients With Neutropenia
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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 IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE FDA Label Details

Indications & Usage

ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE is FDA-approved to treat 5 conditions — same approved indications as ACYCLOVIR SODIUM.

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Data Sources

FDA Approval: ANDA074885 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.