Details for New Drug Application (NDA): 218746
NDA 218746 describes BUMETANIDE, which is a drug marketed by Adaptis, 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-six suppliers. Additional details are available on the BUMETANIDE profile page.
The generic ingredient in BUMETANIDE is bumetanide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
The generic ingredient in BUMETANIDE is bumetanide. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 218746
| Tradename: | BUMETANIDE |
| Applicant: | Aspiro |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 218746
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 218746
Suppliers and Packaging for NDA: 218746
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 218746 | ANDA | Camber Pharmaceuticals, Inc. | 31722-368 | 31722-368-32 | 10 VIAL, SINGLE-DOSE in 1 CARTON (31722-368-32) / 4 mL in 1 VIAL, SINGLE-DOSE (31722-368-31) |
| BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 218746 | ANDA | Camber Pharmaceuticals, Inc. | 31722-369 | 31722-369-32 | 10 VIAL, MULTI-DOSE in 1 CARTON (31722-369-32) / 10 mL in 1 VIAL, MULTI-DOSE (31722-369-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
| Approval Date: | Feb 27, 2025 | TE: | AP | RLD: | No | ||||
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