Details for New Drug Application (NDA): 205473
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The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.
Summary for 205473
Tradename: | ETHACRYNATE SODIUM |
Applicant: | Par Sterile Products |
Ingredient: | ethacrynate sodium |
Patents: | 0 |
Formulation / Manufacturing: | see details |
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 Pharmaceutical, Inc. | 42023-157 | 42023-157-01 | 1 VIAL in 1 CARTON (42023-157-01) / 50 mL in 1 VIAL |
ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 205473 | ANDA | Par Pharmaceutical, Inc. | 42023-157 | 42023-157-99 | 1 VIAL in 1 CARTON (42023-157-99) / 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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