Last Updated: September 24, 2026

Details for New Drug Application (NDA): 074913

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NDA 074913 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hainan Poly, Hikma, Hospira, Pharmobedient, 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 is one drug master file entry for this compound. Eight suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for 074913

Tradename:	ACYCLOVIR SODIUM
Applicant:	Eurohlth Intl Sarl
Ingredient:	acyclovir sodium
Patents:	0

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Oct 15, 1997	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Oct 15, 1997	TE:		RLD:	No

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