Details for New Drug Application (NDA): 217153
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NDA 217153 describes BUMETANIDE, which is a drug marketed by Gland Pharma Ltd, Hospira, Lupin Ltd, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Appco, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in seventeen NDAs. It is available from twenty-six 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-nine 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-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 217153
| Tradename: | BUMETANIDE |
| Applicant: | Lupin Ltd |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 217153
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 217153
Suppliers and Packaging for NDA: 217153
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 217153 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-323 | 70748-323-10 | 10 VIAL in 1 CARTON (70748-323-10) / 4 mL in 1 VIAL |
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 217153 | ANDA | Lupin Pharmaceuticals, Inc. | 70748-323 | 70748-323-11 | 10 VIAL in 1 CARTON (70748-323-11) / 10 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
| Approval Date: | Sep 17, 2024 | TE: | AP | RLD: | No | ||||
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