Last Updated: June 27, 2026

Details for New Drug Application (NDA): 212444

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NDA 212444 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, 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, 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 sixty 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 212444

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

Pharmacology for NDA: 212444

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 212444

Antiviral Agents

Suppliers and Packaging for NDA: 212444

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR	acyclovir	OINTMENT;TOPICAL	212444	ANDA	Macleods Pharmaceuticals Limited	33342-439	33342-439-15	1 TUBE in 1 CARTON (33342-439-15) / 15 g in 1 TUBE
ACYCLOVIR	acyclovir	OINTMENT;TOPICAL	212444	ANDA	Macleods Pharmaceuticals Limited	33342-439	33342-439-30	1 TUBE in 1 CARTON (33342-439-30) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	5%
Approval Date:	May 19, 2021	TE:	AB	RLD:	No

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