Details for New Drug Application (NDA): 206535

NDA 206535 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 206535

Tradename:	ACYCLOVIR SODIUM
Applicant:	Zydus Pharms
Ingredient:	acyclovir sodium
Patents:	0

Pharmacology for NDA: 206535

Mechanism of Action

DNA Polymerase Inhibitors

Suppliers and Packaging for NDA: 206535

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	206535	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-048	68382-048-10	10 VIAL, SINGLE-USE in 1 CARTON (68382-048-10) / 10 mL in 1 VIAL, SINGLE-USE (68382-048-01)
ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	206535	ANDA	Zydus Pharmaceuticals (USA) Inc.	68382-049	68382-049-10	10 VIAL, SINGLE-USE in 1 CARTON (68382-049-10) / 20 mL in 1 VIAL, SINGLE-USE (68382-049-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INJECTION			Strength	EQ 50MG BASE/ML
Approval Date:	Aug 31, 2018	TE:	AP	RLD:	No

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