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Queensland Health
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Generated: March 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201445

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NDA 201445 describes ACYCLOVIR, which is a drug marketed by Actavis Elizabeth, Apotex Inc, Boscogen, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Zydus Pharms Usa Inc, Abbvie, Amneal Pharms, Fougera Pharms Inc, G And W Labs Inc, Glenmark Pharms Ltd, Mylan Pharms Inc, Taro, Tolmar, Actavis Mid Atlantic, Hi Tech Pharma, Carlsbad, Hetero Labs Ltd V, Sun Pharm Inds Ltd, Yiling Pharm Ltd, 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 sixty-two NDAs. It is available from sixty-three suppliers. Additional details are available on the ACYCLOVIR profile page.

The generic ingredient in ACYCLOVIR is acyclovir sodium. There are fifty-five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 201445
Applicant:Cadila Pharms Ltd
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 201445
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 201445
Suppliers and Packaging for NDA: 201445
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir CAPSULE;ORAL 201445 ANDA REMEDYREPACK INC. 70518-0806 N 70518-0806-0
ACYCLOVIR acyclovir CAPSULE;ORAL 201445 ANDA Cadila Pharmaceuticals Limited 71209-004 N 71209-004-10

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength200MG
Approval Date:Mar 6, 2014TE:ABRLD:No

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