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Generated: April 29, 2017

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Details for New Drug Application (NDA): 016092

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NDA 016092 describes EDECRIN, which is a drug marketed by Aton and is included in two NDAs. It is available from four suppliers. Additional details are available on the EDECRIN profile page.

The generic ingredient in EDECRIN is ethacrynate sodium. There are two drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.

Summary for NDA: 016092

Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details

Pharmacology for NDA: 016092

Suppliers and Packaging for NDA: 016092

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ethacrynic acid
TABLET;ORAL 016092 NDA KAISER FOUNDATION HOSPITALS 0179-0126 0179-0126-70 30 TABLET in 1 BOX, UNIT-DOSE (0179-0126-70)
ethacrynic acid
TABLET;ORAL 016092 NDA Aton Pharma, Inc. 25010-215 25010-215-15 100 TABLET in 1 BOTTLE (25010-215-15)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength25MG
Approval Date:Approved Prior to Jan 1, 1982TE:ABRLD:Yes

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength50MG
Approval Date:Approved Prior to Jan 1, 1982TE:RLD:No

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