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Last Updated: December 22, 2024

Details for New Drug Application (NDA): 211794

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NDA 211794 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Adaptis, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Alembic, Amneal, Padagis Israel, Taro, Zydus Lifesciences, Abbvie, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm Llc, Apotex Inc, 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, Norvium Bioscience, Slate Run Pharma, and Teva Parenteral, and is included in ninety NDAs. It is available from sixty-seven 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. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

Summary for 211794

Tradename:	ACYCLOVIR
Applicant:	Cipla
Ingredient:	acyclovir
Patents:	0

Pharmacology for NDA: 211794

Mechanism of Action	DNA Polymerase Inhibitors

Medical Subject Heading (MeSH) Categories for 211794

Antiviral Agents

Suppliers and Packaging for NDA: 211794

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ACYCLOVIR	acyclovir	OINTMENT;TOPICAL	211794	ANDA	Cipla USA Inc.	69097-656	69097-656-38	1 TUBE in 1 CARTON (69097-656-38) / 15 g in 1 TUBE
ACYCLOVIR	acyclovir	OINTMENT;TOPICAL	211794	ANDA	Cipla USA Inc.	69097-656	69097-656-40	1 TUBE in 1 CARTON (69097-656-40) / 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	OINTMENT;TOPICAL			Strength	5%
Approval Date:	Jan 18, 2019	TE:	AB	RLD:	No

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