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Serving hundreds of leading biopharmaceutical companies globally:

Citi
Cantor Fitzgerald
Medtronic
Healthtrust
Federal Trade Commission
McKesson
UBS
Express Scripts
Covington

Generated: May 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 202459

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NDA 202459 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, Alembic Pharms Ltd, 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-three 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. Six suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 202459
Tradename:ACYCLOVIR
Applicant:Mylan Pharms Inc
Ingredient:acyclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 202459
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 202459
Suppliers and Packaging for NDA: 202459
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir OINTMENT;TOPICAL 202459 ANDA Mylan Pharmaceuticals Inc. 0378-8700 N 0378-8700-06
ACYCLOVIR acyclovir OINTMENT;TOPICAL 202459 ANDA Mylan Pharmaceuticals Inc. 0378-8700 N 0378-8700-49

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:OINTMENT;TOPICALStrength5%
Approval Date:Apr 3, 2013TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Covington
Chubb
McKesson
Johnson and Johnson
Cipla
McKinsey
Medtronic
QuintilesIMS

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