Details for New Drug Application (NDA): 213458
NDA 213458 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 213458
| Tradename: | BUMETANIDE |
| Applicant: | Taro |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 213458
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 213458
Suppliers and Packaging for NDA: 213458
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | TABLET;ORAL | 213458 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4223 | 51672-4223-1 | 100 TABLET in 1 BOTTLE (51672-4223-1) |
| BUMETANIDE | bumetanide | TABLET;ORAL | 213458 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-4224 | 51672-4224-1 | 100 TABLET in 1 BOTTLE (51672-4224-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Jul 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Jul 24, 2023 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Jul 24, 2023 | TE: | AB | RLD: | No | ||||
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