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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Julphar
Express Scripts
Teva
Daiichi Sankyo
Healthtrust
UBS
Queensland Health
Harvard Business School

Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 077309

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NDA 077309 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 077309
Tradename:ACYCLOVIR
Applicant:Apotex Inc
Ingredient:acyclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 077309
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 077309
Suppliers and Packaging for NDA: 077309
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir TABLET;ORAL 077309 ANDA Liberty Pharmaceuticals, Inc. 0440-7033 N 0440-7033-81
ACYCLOVIR acyclovir TABLET;ORAL 077309 ANDA Major Pharmaceuticals 0904-5790 N 0904-5790-61

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Sep 29, 2005TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Sep 29, 2005TE:ABRLD:No

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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Medtronic
Farmers Insurance
Cerilliant
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McKinsey
Baxter
Healthtrust
Express Scripts

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