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Last Updated: December 19, 2025

Details for New Drug Application (NDA): 074930

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NDA 074930 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 074930

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

Pharmacology for NDA: 074930

Mechanism of Action	DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 074930

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	074930	ANDA	Fresenius Kabi USA, LLC	63323-325	63323-325-14	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-14) / 10 mL in 1 VIAL, SINGLE-DOSE (63323-325-41)
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	074930	ANDA	Fresenius Kabi USA, LLC	63323-325	63323-325-24	10 VIAL, SINGLE-DOSE in 1 TRAY (63323-325-24) / 20 mL in 1 VIAL, SINGLE-DOSE (63323-325-43)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	May 13, 1998	TE:	AP	RLD:	No

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