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Last Updated: June 9, 2023

Details for New Drug Application (NDA): 016092

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

The generic ingredient in EDECRIN is ethacrynic acid. There are thirteen drug master file entries for this compound. Ten suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.
Summary for 016092
Ingredient:ethacrynic acid
Formulation / Manufacturing:see details
Pharmacology for NDA: 016092
Medical Subject Heading (MeSH) Categories for 016092
Suppliers and Packaging for NDA: 016092
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
EDECRIN ethacrynic acid TABLET;ORAL 016092 NDA Bausch Health US, LLC 25010-215 25010-215-15 100 TABLET in 1 BOTTLE (25010-215-15)
EDECRIN ethacrynic acid TABLET;ORAL 016092 NDA AUTHORIZED GENERIC Oceanside Pharmaceuticals 68682-011 68682-011-10 100 TABLET in 1 BOTTLE (68682-011-10)

Profile for product number 001

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

Profile 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson

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