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Serving leading biopharmaceutical companies globally:

Fuji
Harvard Business School
US Army
Healthtrust
Farmers Insurance
Argus Health
Boehringer Ingelheim
Merck
Moodys
Mallinckrodt

Generated: January 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 seven suppliers. Additional details are available on the ACYCLOVIR SODIUM profile page.

The generic ingredient in ACYCLOVIR SODIUM 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 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 55150-154-10 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-10) > 10 mL in 1 VIAL, SINGLE-DOSE
ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 203701 ANDA AuroMedics Pharma LLC 55150-154 55150-154-11 10 VIAL, SINGLE-DOSE in 1 CARTON (55150-154-11) > 10 mL in 1 VIAL, SINGLE-DOSE

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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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
Daiichi Sankyo
Chinese Patent Office
Federal Trade Commission
Julphar
Teva
Harvard Business School
Cantor Fitzgerald

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