You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 15, 2025

Details for New Drug Application (NDA): 215404

✉ Email this page to a colleague

« Back to Dashboard

NDA 215404 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hikma, Hospira, Pharmobedient, Slate Run Pharma, Teva Parenteral, and Zydus Pharms, and is included in nineteen NDAs. It is available from eight suppliers. Additional details are available on the ACYCLOVIR SODIUM profile page.

The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-six drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for 215404

Tradename:	ACYCLOVIR SODIUM
Applicant:	Fresenius Kabi Usa
Ingredient:	acyclovir sodium
Patents:	0

Pharmacology for NDA: 215404

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 215404

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	215404	ANDA	Fresenius Kabi USA, LLC	65219-622	65219-622-10	10 VIAL in 1 CARTON (65219-622-10) / 10 mL in 1 VIAL (65219-622-02)
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	215404	ANDA	Fresenius Kabi USA, LLC	65219-624	65219-624-20	10 VIAL in 1 CARTON (65219-624-20) / 20 mL in 1 VIAL (65219-624-04)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Jun 25, 2024	TE:	AP	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.