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Colorcon
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Generated: June 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203701

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NDA 203701 describes ACYCLOVIR SODIUM, which is a drug marketed by Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hikma Pharms, Hospira, Mylan Labs Ltd, Teva Parenteral, and Zydus Pharms Usa Inc, and is included in fifteen NDAs. It is available from six suppliers. Additional details are available on the ACYCLOVIR SODIUM profile page.

The generic ingredient in ACYCLOVIR SODIUM 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 203701
Tradename:ACYCLOVIR SODIUM
Applicant:Aurobindo Pharma Ltd
Ingredient:acyclovir sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203701
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Suppliers and Packaging for NDA: 203701
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 203701 ANDA AuroMedics Pharma LLC 55150-154 N 55150-154-10
ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 203701 ANDA AuroMedics Pharma LLC 55150-154 N 55150-154-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/ML
Approval Date:Oct 11, 2013TE:APRLD:No

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