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Last Updated: September 21, 2020

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, Par Sterile Products, Vpi Pharms Inc, and Zydus Pharms, and is included in four 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
Applicant:Mylan Institutional
Ingredient:ethacrynate sodium
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

Approval Date:Aug 23, 2016TE:APRLD:No

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