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FDA Drug information

Ethacrynate Sodium

Read time: 1 mins
Marketing start date: 28 Dec 2024

Summary of product characteristics


Effective Time

20221017

Version

3

Spl Product Data Elements

Ethacrynate Sodium Ethacrynate Sodium ETHACRYNATE SODIUM ETHACRYNIC ACID MANNITOL

Application Number

ANDA207758

Brand Name

Ethacrynate Sodium

Generic Name

Ethacrynate Sodium

Product Ndc

70771-1106

Product Type

HUMAN PRESCRIPTION DRUG

Route

INTRAVENOUS

Package Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 MG SINGLE DOSE VIAL CONTAINER LABEL NDC 70771-1106-1 Ethacrynate Sodium for Injection, USP 50 mg/vial* *50 mg Ethacrynic Acid Equivalent For Intravenous Use SINGLE DOSE VIAL Rx only PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 50 MG SINGLE DOSE VIAL CARTON LABEL NDC 70771-1106-1 Ethacrynate Sodium for Injection, USP 50 mg/vial* *50 mg Ethacrynic Acid Equivalent For Intravenous Use FOR THE PREPARATION OF INTRAVENOUS SOLUTIONS ETHACRYNATE SODIUM (active ingredient) SINGLE DOSE VIAL Rx only Container Label Carton Label

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