Details for New Drug Application (NDA): 016093
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NDA 016093 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 016093
| Tradename: | EDECRIN |
| Applicant: | Bausch |
| Ingredient: | ethacrynate sodium |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 016093
| Physiological Effect | Increased Diuresis at Loop of Henle |
Suppliers and Packaging for NDA: 016093
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EDECRIN | ethacrynate sodium | INJECTABLE;INJECTION | 016093 | NDA | Bausch Health US, LLC | 25010-210 | 25010-210-27 | 1 VIAL in 1 CARTON (25010-210-27) / 50 mL in 1 VIAL |
| EDECRIN | ethacrynate sodium | INJECTABLE;INJECTION | 016093 | NDA AUTHORIZED GENERIC | Oceanside Pharmaceuticals | 68682-012 | 68682-012-50 | 1 VIAL in 1 CARTON (68682-012-50) / 50 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | EQ 50MG BASE/VIAL | ||||
| Approval Date: | Approved Prior to Jan 1, 1982 | TE: | AP | RLD: | Yes | ||||
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