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Generated: April 30, 2017

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Details for New Drug Application (NDA): 205609

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

The generic ingredient in ETHACRYNIC ACID is ethacrynic acid. There are ten drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.

Summary for NDA: 205609

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 205609

Suppliers and Packaging for NDA: 205609

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethacrynic acid
TABLET;ORAL 205609 ANDA Edenbridge Pharmaceuticals, LLC 42799-405 42799-405-01 100 TABLET in 1 BOTTLE (42799-405-01)
ethacrynic acid
TABLET;ORAL 205609 ANDA Ingenus Pharmaceuticals NJ, LLC 52682-048 52682-048-01 100 TABLET in 1 BOTTLE (52682-048-01)

Summary for product number 001

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

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