Details for New Drug Application (NDA): 205473
NDA 205473 describes ETHACRYNATE SODIUM, which is a drug marketed by Mylan Institutional, Ph Health, Sterimax, and Zydus Pharms, and is included in four NDAs. It is available from two suppliers. Additional details are available on the ETHACRYNATE SODIUM profile page.
The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.
The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.
Summary for 205473
| Tradename: | ETHACRYNATE SODIUM |
| Applicant: | Ph Health |
| Ingredient: | ethacrynate sodium |
| Patents: | 0 |
Pharmacology for NDA: 205473
| Physiological Effect | Increased Diuresis at Loop of Henle |
Suppliers and Packaging for NDA: 205473
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 205473 | ANDA | Par Health USA, LLC | 42023-157 | 42023-157-01 | 1 VIAL in 1 CARTON (42023-157-01) / 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: | Jul 29, 2015 | TE: | AP | RLD: | No | ||||
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