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Last Updated: May 28, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 208702


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NDA 208702 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Kenton, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Perrigo Uk Finco, Abbvie, Acp Nimble, Alembic Pharms Ltd, Amneal Pharms, Cipla, Fougera Pharms Inc, Glenmark Pharms Sa, Mylan Pharms Inc, Solaris Pharma Corp, Taro, Tolmar, Torrent, Xiromed, Actavis Mid Atlantic, Hi Tech Pharma, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms Ltd, Sun Pharm Inds Ltd, Yiling Pharm Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hikma Pharms, Hospira, Mylan Labs Ltd, and Teva Parenteral, and is included in seventy-three NDAs. It is available from fifty-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. Five suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 208702
Tradename:ACYCLOVIR
Applicant:Perrigo Uk Finco
Ingredient:acyclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 208702
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 208702
Suppliers and Packaging for NDA: 208702
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir CREAM;TOPICAL 208702 ANDA Perrigo New York Inc 45802-044 45802-044-75 1 TUBE in 1 CARTON (45802-044-75) > 5 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CREAM;TOPICALStrength5%
Approval Date:Feb 4, 2019TE:ABRLD:No

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