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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Queensland Health
Deloitte
Teva
Chubb
Cerilliant
Johnson and Johnson
Moodys
Cantor Fitzgerald
UBS

Generated: January 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075211

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NDA 075211 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, 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-one NDAs. It is available from sixty-four 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. Seven suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 075211
Tradename:ACYCLOVIR
Applicant:Mylan Pharms Inc
Ingredient:acyclovir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 075211
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 075211
Suppliers and Packaging for NDA: 075211
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir TABLET;ORAL 075211 ANDA Mylan Pharmaceuticals Inc. 0378-0253 0378-0253-01 100 TABLET in 1 BOTTLE, PLASTIC (0378-0253-01)
ACYCLOVIR acyclovir TABLET;ORAL 075211 ANDA State of Florida DOH Central Pharmacy 53808-0609 53808-0609-1 30 TABLET in 1 BLISTER PACK (53808-0609-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Sep 28, 1998TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Sep 28, 1998TE:ABRLD:No

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Serving leading biopharmaceutical companies globally:

Accenture
Julphar
US Department of Justice
QuintilesIMS
Fish and Richardson
Healthtrust
Deloitte
Covington
Daiichi Sankyo

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