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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 016093


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NDA 016093 describes EDECRIN, which is a drug marketed by Bausch and is included in two NDAs. It is available from two suppliers. Additional details are available on the EDECRIN profile page.

The generic ingredient in EDECRIN is ethacrynic acid. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.
Summary for 016093
Tradename:EDECRIN
Applicant:Bausch
Ingredient:ethacrynate sodium
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 016093
Suppliers and Packaging for NDA: 016093
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EDECRIN ethacrynate sodium INJECTABLE;INJECTION 016093 NDA Bausch Health US, LLC 25010-210 25010-210-27 1 VIAL in 1 CARTON (25010-210-27) / 50 mL in 1 VIAL
EDECRIN ethacrynate sodium INJECTABLE;INJECTION 016093 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-012 68682-012-27 1 VIAL in 1 CARTON (68682-012-27) / 50 mL in 1 VIAL

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrengthEQ 50MG BASE/VIAL
Approval Date:Approved Prior to Jan 1, 1982TE:APRLD:Yes

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