Details for New Drug Application (NDA): 208805
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NDA 208805 describes ETHACRYNIC ACID, which is a drug marketed by Agnitio, Alvogen, Amneal Pharms Co, Chartwell Rx, Edenbridge Pharms, Hikma, Lupin Ltd, Par Pharm Inc, Sciegen Pharms Inc, and Upsher Smith Labs, and is included in ten NDAs. It is available from eight 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. Ten 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. Ten suppliers are listed for this compound. Additional details are available on the ethacrynic acid profile page.
Summary for 208805
| Tradename: | ETHACRYNIC ACID |
| Applicant: | Amneal Pharms Co |
| Ingredient: | ethacrynic acid |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 208805
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 208805
Suppliers and Packaging for NDA: 208805
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ETHACRYNIC ACID | ethacrynic acid | TABLET;ORAL | 208805 | ANDA | Amneal Pharmaceuticals NY LLC | 69238-1126 | 69238-1126-1 | 100 TABLET in 1 BOTTLE (69238-1126-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 25MG | ||||
| Approval Date: | May 8, 2018 | TE: | AB | RLD: | No | ||||
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