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Generated: February 24, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 205609

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NDA 205609 describes ETHACRYNIC ACID, which is a drug marketed by Edenbridge Pharms, Par Pharm Inc, and West-ward Pharms Int, and is included in three NDAs. It is available from five suppliers. Additional details are available on the ETHACRYNIC ACID profile page.

The generic ingredient in ETHACRYNIC ACID is ethacrynic acid. There are twelve drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.
Summary for 205609
Tradename:ETHACRYNIC ACID
Applicant:Edenbridge Pharms
Ingredient:ethacrynic acid
Patents:0
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 205609
Medical Subject Heading (MeSH) Categories for 205609
Suppliers and Packaging for NDA: 205609
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHACRYNIC ACID ethacrynic acid TABLET;ORAL 205609 ANDA Edenbridge Pharmaceuticals, LLC 42799-405 N 42799-405-01
ETHACRYNIC ACID ethacrynic acid TABLET;ORAL 205609 ANDA Ingenus Pharmaceuticals NJ, LLC 52682-048 N 52682-048-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Jun 30, 2016TE:ABRLD:No

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