Last Updated: September 29, 2026

Details for New Drug Application (NDA): 203834

✉ Email this page to a colleague

« Back to Dashboard

NDA 203834 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad, 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 Pharms Nc, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms, Pharmobedient, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon Research, Vistapharm Llc, 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, Hainan Poly, Hospira, and Teva Parenteral, and is included in ninety-one NDAs. It is available from sixty suppliers. Additional details are available on the ACYCLOVIR profile page.

The generic ingredient in ACYCLOVIR is acyclovir sodium. There are two 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 203834

Tradename:	ACYCLOVIR
Applicant:	Hetero Labs Ltd V
Ingredient:	acyclovir
Patents:	0

Pharmacology for NDA: 203834

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 203834

Antiviral Agents

Suppliers and Packaging for NDA: 203834

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR	acyclovir	TABLET;ORAL	203834	ANDA	Major Pharmaceuticals	0904-7507	0904-7507-61	100 BLISTER PACK in 1 CARTON (0904-7507-61) / 1 TABLET in 1 BLISTER PACK
ACYCLOVIR	acyclovir	TABLET;ORAL	203834	ANDA	Camber Pharmaceuticals, Inc.	31722-777	31722-777-01	100 TABLET in 1 BOTTLE (31722-777-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Oct 29, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Oct 29, 2013	TE:	AB	RLD:	No

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.