Details for New Drug Application (NDA): 216434
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NDA 216434 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-five 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-eight 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-eight suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 216434
| Tradename: | BUMETANIDE |
| Applicant: | Gland Pharma Ltd |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 216434
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 216434
Suppliers and Packaging for NDA: 216434
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 216434 | ANDA | Fresenius Kabi USA, LLC | 65219-570 | 65219-570-04 | 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-570-04) / 4 mL in 1 VIAL, SINGLE-DOSE (65219-570-01) |
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 216434 | ANDA | Fresenius Kabi USA, LLC | 65219-572 | 65219-572-10 | 10 VIAL, MULTI-DOSE in 1 CARTON (65219-572-10) / 10 mL in 1 VIAL, MULTI-DOSE (65219-572-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
| Approval Date: | May 26, 2022 | TE: | AP | RLD: | No | ||||
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