Details for New Drug Application (NDA): 212417
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NDA 212417 describes ETHACRYNIC ACID, which is a drug marketed by Adaptis, Agnitio, Alvogen, Amneal Pharms Co, Chartwell Rx, Endo Operations, Hikma, Lupin Ltd, Sciegen Pharms Inc, and Upsher Smith Labs, and is included in ten NDAs. It is available from seven suppliers. Additional details are available on the ETHACRYNIC ACID profile page.
The generic ingredient in ETHACRYNIC ACID is ethacrynic acid. There are thirteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.
The generic ingredient in ETHACRYNIC ACID is ethacrynic acid. There are thirteen drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.
Summary for 212417
| Tradename: | ETHACRYNIC ACID |
| Applicant: | Upsher Smith Labs |
| Ingredient: | ethacrynic acid |
| Patents: | 0 |
Pharmacology for NDA: 212417
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 212417
Suppliers and Packaging for NDA: 212417
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHACRYNIC ACID | ethacrynic acid | TABLET;ORAL | 212417 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1690 | 0832-1690-11 | 100 TABLET in 1 BOTTLE (0832-1690-11) |
| ETHACRYNIC ACID | ethacrynic acid | TABLET;ORAL | 212417 | ANDA | Upsher-Smith Laboratories, LLC | 0832-1690 | 0832-1690-30 | 30 TABLET in 1 BOTTLE (0832-1690-30) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | Feb 19, 2020 | TE: | AB | RLD: | No | ||||
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