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Chubb
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Generated: January 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 204634

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NDA 204634 describes ETHACRYNATE SODIUM, which is a drug marketed by Mylan Institutional and Par Sterile Products and is included in two NDAs. It is available from two suppliers. Additional details are available on the ETHACRYNATE SODIUM profile page.

The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.
Summary for 204634
Tradename:ETHACRYNATE SODIUM
Applicant:Mylan Institutional
Ingredient:ethacrynate sodium
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 204634
Suppliers and Packaging for NDA: 204634
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHACRYNATE SODIUM ethacrynate sodium INJECTABLE;INJECTION 204634 ANDA Mylan Institutional LLC 67457-297 67457-297-50 1 VIAL, SINGLE-DOSE in 1 CARTON (67457-297-50) > 50 mL in 1 VIAL, SINGLE-DOSE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Aug 23, 2016TE:APRLD:No

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Serving leading biopharmaceutical companies globally:

Moodys
Colorcon
Cipla
Boehringer Ingelheim
Covington
Harvard Business School
QuintilesIMS
Teva
Fish and Richardson

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