Last Updated: September 24, 2026

Details for New Drug Application (NDA): 202168

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NDA 202168 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 202168

Tradename:	ACYCLOVIR
Applicant:	Cadila Pharms Ltd
Ingredient:	acyclovir
Patents:	0

Pharmacology for NDA: 202168

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 202168

Antiviral Agents

Suppliers and Packaging for NDA: 202168

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR	acyclovir	TABLET;ORAL	202168	ANDA	Cadila Pharmaceuticals Limited	71209-005	71209-005-05	100 TABLET in 1 BOTTLE (71209-005-05)
ACYCLOVIR	acyclovir	TABLET;ORAL	202168	ANDA	Cadila Pharmaceuticals Limited	71209-005	71209-005-10	500 TABLET in 1 BOTTLE (71209-005-10)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	400MG
Approval Date:	Nov 15, 2013	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	800MG
Approval Date:	Nov 15, 2013	TE:	AB	RLD:	No

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