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Generated: December 12, 2018

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Details for New Drug Application (NDA): 204634

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NDA 204634 describes ETHACRYNATE SODIUM, which is a drug marketed by Mylan Institutional, Par Sterile Products, and Zydus Pharms Usa Inc, and is included in three NDAs. It is available from four 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. Six 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
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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