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Last Updated: December 18, 2025

Details for New Drug Application (NDA): 204314

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NDA 204314 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Regcon Holdings, Roxane, Strides Pharma Intl, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Cipla, Padagis Israel, Sun Pharma Canada, Zydus Lifesciences, Abbvie, Amneal Pharms, Chartwell Molecular, Chartwell Rx, Cosette, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms Ltd, Pharmobedient, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon Research, Vistapharm Llc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Slate Run Pharma, and Teva Parenteral, and is included in ninety-one NDAs. It is available from fifty-nine suppliers. Additional details are available on the ACYCLOVIR profile page.

The generic ingredient in ACYCLOVIR 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 204314

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

Pharmacology for NDA: 204314

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 204314

Antiviral Agents

Suppliers and Packaging for NDA: 204314

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR	acyclovir	TABLET;ORAL	204314	ANDA	A-S Medication Solutions	50090-3250	50090-3250-0	2 TABLET in 1 BOTTLE (50090-3250-0)
ACYCLOVIR	acyclovir	TABLET;ORAL	204314	ANDA	A-S Medication Solutions	50090-3250	50090-3250-2	25 TABLET in 1 BOTTLE (50090-3250-2)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Aug 19, 2014	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Aug 19, 2014	TE:	AB	RLD:	No

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