Details for New Drug Application (NDA): 212019
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NDA 212019 describes BUMETANIDE, which is a drug marketed by Aspiro, Gland Pharma Ltd, Hospira, Lupin Ltd, MSN, Qilu Pharm Hainan, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Appco, Heritage Pharma, Rising, Rubicon, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in nineteen NDAs. It is available from twenty-eight 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. Thirty 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. Thirty suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 212019
| Tradename: | BUMETANIDE |
| Applicant: | Rising |
| Ingredient: | bumetanide |
| Patents: | 0 |
Pharmacology for NDA: 212019
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 212019
Suppliers and Packaging for NDA: 212019
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | TABLET;ORAL | 212019 | ANDA | Rising Pharma Holdings, Inc | 16571-677 | 16571-677-01 | 100 TABLET in 1 BOTTLE (16571-677-01) |
| BUMETANIDE | bumetanide | TABLET;ORAL | 212019 | ANDA | Rising Pharma Holdings, Inc | 16571-677 | 16571-677-10 | 1000 TABLET in 1 BOTTLE (16571-677-10) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Dec 12, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Dec 12, 2019 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Dec 12, 2019 | TE: | AB | RLD: | No | ||||
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