Details for New Drug Application (NDA): 075768
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The generic ingredient in BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 075768
Tradename: | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
Applicant: | Mylan |
Ingredient: | bisoprolol fumarate; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 075768
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 075768
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 075768 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0501 | 0378-0501-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0501-01) |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 075768 | ANDA | Mylan Pharmaceuticals Inc. | 0378-0503 | 0378-0503-01 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-0503-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;6.25MG | ||||
Approval Date: | Sep 25, 2000 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;6.25MG | ||||
Approval Date: | Sep 25, 2000 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;6.25MG | ||||
Approval Date: | Sep 25, 2000 | TE: | AB | RLD: | No |
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