Details for New Drug Application (NDA): 079196
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The generic ingredient in BUMETANIDE is bumetanide. There are six drug master file entries for this compound. Twenty-eight suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 079196
Tradename: | BUMETANIDE |
Applicant: | West-ward Pharms Int |
Ingredient: | bumetanide |
Patents: | 0 |
Pharmacology for NDA: 079196
Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 079196
Suppliers and Packaging for NDA: 079196
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 079196 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6007 | 0641-6007-10 | 10 VIAL in 1 CARTON (0641-6007-10) / 10 mL in 1 VIAL (0641-6007-01) |
BUMETANIDE | bumetanide | INJECTABLE;INJECTION | 079196 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6008 | 0641-6008-10 | 10 VIAL in 1 CARTON (0641-6008-10) / 4 mL in 1 VIAL (0641-6008-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | INJECTABLE;INJECTION | Strength | 0.25MG/ML | ||||
Approval Date: | Apr 30, 2008 | TE: | AP | RLD: | No |
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