Details for New Drug Application (NDA): 209916
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NDA 209916 describes BUMETANIDE, which is a drug marketed by Gland Pharma Ltd, Hospira, MSN, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-three suppliers. Additional details are available on the BUMETANIDE profile page.
The generic ingredient in BUMETANIDE is bumetanide. There are six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
The generic ingredient in BUMETANIDE is bumetanide. There are six drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 209916
| Tradename: | BUMETANIDE |
| Applicant: | Upsher Smith Labs |
| Ingredient: | bumetanide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 209916
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 209916
Suppliers and Packaging for NDA: 209916
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | TABLET;ORAL | 209916 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0540 | 0832-0540-11 | 100 TABLET in 1 BOTTLE (0832-0540-11) |
| BUMETANIDE | bumetanide | TABLET;ORAL | 209916 | ANDA | Upsher-Smith Laboratories, LLC | 0832-0541 | 0832-0541-10 | 1000 TABLET in 1 BOTTLE (0832-0541-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jan 23, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jan 23, 2018 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jan 23, 2018 | TE: | AB | RLD: | No | ||||
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