Details for New Drug Application (NDA): 205771

NDA 205771 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hikma, Hospira, Norvium Bioscience, Slate Run Pharma, Teva Parenteral, and Zydus Pharms, and is included in nineteen NDAs. It is available from nine 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. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for 205771

Tradename:	ACYCLOVIR SODIUM
Applicant:	Hikma
Ingredient:	acyclovir sodium
Patents:	0

Pharmacology for NDA: 205771

Mechanism of Action

DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 205771

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	205771	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9657	0143-9657-10	10 VIAL, SINGLE-DOSE in 1 BOX (0143-9657-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9657-01)
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	205771	ANDA	Hikma Pharmaceuticals USA Inc.	0143-9658	0143-9658-10	10 VIAL, SINGLE-DOSE in 1 BOX (0143-9658-10) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE (0143-9658-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 500MG BASE/VIAL
Approval Date:	Feb 29, 2016	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	INJECTABLE;INJECTION			Strength	EQ 1GM BASE/VIAL
Approval Date:	Feb 29, 2016	TE:		RLD:	No

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