Details for New Drug Application (NDA): 212931
NDA 212931 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 212931
| Tradename: | BUMETANIDE |
| Applicant: | Appco |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 212931
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 212931
Suppliers and Packaging for NDA: 212931
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | TABLET;ORAL | 212931 | ANDA | Solco Healthcare LLC | 43547-896 | 43547-896-10 | 100 TABLET in 1 BOTTLE (43547-896-10) |
| BUMETANIDE | bumetanide | TABLET;ORAL | 212931 | ANDA | Solco Healthcare LLC | 43547-897 | 43547-897-10 | 100 TABLET in 1 BOTTLE (43547-897-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Sep 18, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Sep 18, 2024 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Sep 18, 2024 | TE: | AB | RLD: | No | ||||
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