Details for New Drug Application (NDA): 215562
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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 215562
Tradename: | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
Applicant: | Novitium Pharma |
Ingredient: | bisoprolol fumarate; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 215562
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 215562
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 215562 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-740 | 10135-740-01 | 100 TABLET in 1 BOTTLE (10135-740-01) |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 215562 | ANDA | Marlex Pharmaceuticals, Inc. | 10135-740 | 10135-740-05 | 500 TABLET in 1 BOTTLE (10135-740-05) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;6.25MG | ||||
Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG;6.25MG | ||||
Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG;6.25MG | ||||
Approval Date: | Nov 4, 2021 | TE: | AB | RLD: | No |
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