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Last Updated: April 21, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204605

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NDA 204605 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, Yiling, Amneal, Perrigo Uk Finco, Abbvie, Alembic Pharms Ltd, Amneal Pharms, Anda Repository, Cipla, Cosette, Fougera Pharms Inc, Glenmark Pharms Sa, Mylan Pharms Inc, Solaris Pharma Corp, Taro, Torrent, Xiromed, Actavis Mid Atlantic, Akorn, Novitium Pharma, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms Ltd, Sun Pharm Inds Ltd, Zydus Pharms, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Exela Pharma, Fresenius Kabi Usa, Hikma, Hospira, Mylan Labs Ltd, and Teva Parenteral, and is included in seventy-eight NDAs. It is available from fifty-eight 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 204605
Applicant:Amneal Pharms
Formulation / Manufacturing:see details
Pharmacology for NDA: 204605
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 204605
Suppliers and Packaging for NDA: 204605
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir OINTMENT;TOPICAL 204605 ANDA NorthStar Rx LLC 16714-668 16714-668-01 1 TUBE in 1 CARTON (16714-668-01) > 15 g in 1 TUBE
ACYCLOVIR acyclovir OINTMENT;TOPICAL 204605 ANDA NorthStar Rx LLC 16714-668 16714-668-02 1 TUBE in 1 CARTON (16714-668-02) > 30 g in 1 TUBE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Jun 18, 2014TE:ABRLD:No

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