Details for New Drug Application (NDA): 018225
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The generic ingredient in BUMEX is bumetanide. There are six drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 018225
Tradename: | BUMEX |
Applicant: | Validus Pharms |
Ingredient: | bumetanide |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 018225
Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 018225
Suppliers and Packaging for NDA: 018225
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUMEX | bumetanide | TABLET;ORAL | 018225 | NDA | Validus Pharmaceuticals LLC | 30698-630 | 30698-630-01 | 100 TABLET in 1 BOTTLE (30698-630-01) |
BUMEX | bumetanide | TABLET;ORAL | 018225 | NDA | Validus Pharmaceuticals LLC | 30698-631 | 30698-631-01 | 100 TABLET in 1 BOTTLE (30698-631-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 28, 1983 | TE: | AB | RLD: | Yes |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Feb 28, 1983 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | ||||
Approval Date: | Jun 14, 1985 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 018225
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-003 | Jun 14, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-002 | Feb 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-003 | Jun 14, 1985 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-001 | Feb 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
Validus Pharms | BUMEX | bumetanide | TABLET;ORAL | 018225-002 | Feb 28, 1983 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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