Details for New Drug Application (NDA): 215666
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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 215666
Tradename: | BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE |
Applicant: | Cadila |
Ingredient: | bisoprolol fumarate; hydrochlorothiazide |
Patents: | 0 |
Pharmacology for NDA: 215666
Mechanism of Action | Adrenergic beta-Antagonists |
Physiological Effect | Increased Diuresis |
Suppliers and Packaging for NDA: 215666
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 215666 | ANDA | Zydus Lifesciences Limited | 70771-1760 | 70771-1760-1 | 100 TABLET, FILM COATED in 1 BOTTLE (70771-1760-1) |
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE | bisoprolol fumarate; hydrochlorothiazide | TABLET;ORAL | 215666 | ANDA | Zydus Lifesciences Limited | 70771-1760 | 70771-1760-3 | 30 TABLET, FILM COATED in 1 BOTTLE (70771-1760-3) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG;6.25MG | ||||
Approval Date: | Nov 4, 2022 | 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, 2022 | 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, 2022 | TE: | AB | RLD: | No |
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