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.
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
| Tradename: | EDECRIN |
| Applicant: | Bausch |
| Ingredient: | ethacrynic acid |
| Patents: | 0 |
Pharmacology for NDA: 016092
| Physiological Effect | Increased Diuresis at Loop of Henle |
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: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AB | RLD: | Yes | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | 50MG | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | RLD: | No | |||||
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