Details for New Drug Application (NDA): 207758
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NDA 207758 describes ETHACRYNATE SODIUM, which is a drug marketed by Endo Operations, Mylan Institutional, Sterimax, and Zydus Pharms, and is included in four NDAs. It is available from five suppliers. Additional details are available on the ETHACRYNATE SODIUM profile page.
The generic ingredient in ETHACRYNATE SODIUM is ethacrynate sodium. There are three drug master file entries for this compound. Five 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 are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the ethacrynate sodium profile page.
Summary for 207758
| Tradename: | ETHACRYNATE SODIUM |
| Applicant: | Zydus Pharms |
| Ingredient: | ethacrynate sodium |
| Patents: | 0 |
Pharmacology for NDA: 207758
| Physiological Effect | Increased Diuresis at Loop of Henle |
Suppliers and Packaging for NDA: 207758
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 207758 | ANDA | Zydus Pharmaceuticals USA Inc. | 68382-246 | 68382-246-01 | 1 VIAL in 1 CARTON (68382-246-01) / 50 mL in 1 VIAL |
| ETHACRYNATE SODIUM | ethacrynate sodium | INJECTABLE;INJECTION | 207758 | ANDA | Zydus Lifesciences Limited | 70771-1106 | 70771-1106-1 | 1 VIAL in 1 CARTON (70771-1106-1) / 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: | Nov 17, 2017 | TE: | AP | RLD: | No | ||||
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