Details for New Drug Application (NDA): 219116
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NDA 219116 describes BUMETANIDE, which is a drug marketed by Anthea Pharma, Aspiro, Gland, Hospira, Lupin, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Appco, Heritage Pharma, Jubilant Generics, Mankind Pharma, Rising, Rubicon Research, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in twenty-three NDAs. It is available from thirty-seven 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. Forty-one 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. Forty-one suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 219116
| Tradename: | BUMETANIDE |
| Applicant: | Qilu Pharm Hainan |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 219116
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 219116
Suppliers and Packaging for NDA: 219116
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 219116 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0593 | 67184-0593-2 | 10 VIAL in 1 CARTON (67184-0593-2) / 4 mL in 1 VIAL (67184-0593-1) |
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 219116 | ANDA | Qilu Pharmaceutical Co., Ltd. | 67184-0594 | 67184-0594-2 | 10 VIAL in 1 CARTON (67184-0594-2) / 10 mL in 1 VIAL (67184-0594-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
| Approval Date: | Sep 19, 2024 | TE: | AP | RLD: | No | ||||
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