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Generated: October 16, 2018

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Details for New Drug Application (NDA): 075382

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NDA 075382 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-four NDAs. It is available from sixty-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. Six suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.
Summary for 075382
Tradename:ACYCLOVIR
Applicant:Carlsbad
Ingredient:acyclovir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 075382
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 075382
Suppliers and Packaging for NDA: 075382
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR acyclovir TABLET;ORAL 075382 ANDA Rebel Distributors Corp 42254-133 42254-133-15 15 TABLET in 1 BOTTLE (42254-133-15)
ACYCLOVIR acyclovir TABLET;ORAL 075382 ANDA Rebel Distributors Corp 42254-133 42254-133-20 20 TABLET in 1 BOTTLE (42254-133-20)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength400MG
Approval Date:Apr 30, 1999TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength800MG
Approval Date:Apr 30, 1999TE:ABRLD:No

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