Details for New Drug Application (NDA): 215364
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The generic ingredient in BUMETANIDE is bumetanide. There are six drug master file entries for this compound. Twenty-nine suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 215364
Tradename: | BUMETANIDE |
Applicant: | Msn |
Ingredient: | bumetanide |
Patents: | 0 |
Pharmacology for NDA: 215364
Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 215364
Suppliers and Packaging for NDA: 215364
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 215364 | ANDA | Cardinal Health 107, LLC | 55154-1527 | 55154-1527-5 | 5 VIAL in 1 BAG (55154-1527-5) / 4 mL in 1 VIAL |
BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 215364 | ANDA | Novadoz Pharmaceuticals LLC | 72205-101 | 72205-101-07 | 10 VIAL in 1 CARTON (72205-101-07) / 4 mL in 1 VIAL (72205-101-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
Approval Date: | Aug 4, 2022 | TE: | AP | RLD: | No |
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