Details for New Drug Application (NDA): 074225
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NDA 074225 describes BUMETANIDE, which is a drug marketed by Gland Pharma Ltd, Hospira, MSN, Sagent, Teva Parenteral, West-ward Pharms Int, Amneal Pharms Co, Heritage Pharma, Rising, Sandoz, Taro, Upsher Smith Labs, and Zydus Pharms, and is included in fourteen NDAs. It is available from twenty-three 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. Twenty-six 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. Twenty-six suppliers are listed for this compound. Additional details are available on the bumetanide profile page.
Summary for 074225
| Tradename: | BUMETANIDE |
| Applicant: | Heritage Pharma |
| Ingredient: | bumetanide |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 074225
| Physiological Effect | Increased Diuresis at Loop of Henle |
Medical Subject Heading (MeSH) Categories for 074225
Suppliers and Packaging for NDA: 074225
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BUMETANIDE | bumetanide | TABLET;ORAL | 074225 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-700 | 14539-700-01 | 100 TABLET in 1 BOTTLE (14539-700-01) |
| BUMETANIDE | bumetanide | TABLET;ORAL | 074225 | ANDA | Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. | 14539-700 | 14539-700-05 | 500 TABLET in 1 BOTTLE (14539-700-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 0.5MG | ||||
| Approval Date: | Apr 24, 1995 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Apr 24, 1995 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2MG | ||||
| Approval Date: | Apr 24, 1995 | TE: | AB | RLD: | No | ||||
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