Details for New Drug Application (NDA): 217617
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The generic ingredient in BISOPROLOL FUMARATE 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 217617
Tradename: | BISOPROLOL FUMARATE |
Applicant: | Harman Finochem |
Ingredient: | bisoprolol fumarate |
Patents: | 0 |
Pharmacology for NDA: 217617
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 217617
Suppliers and Packaging for NDA: 217617
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 217617 | ANDA | Sun Pharmaceutical Industries Limited | 70095-019 | 70095-019-01 | 30 TABLET, FILM COATED in 1 BOTTLE, UNIT-DOSE (70095-019-01) |
BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 217617 | ANDA | Sun Pharmaceutical Industries Limited | 70095-019 | 70095-019-02 | 100 TABLET, FILM COATED in 1 BOTTLE (70095-019-02) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Jan 18, 2024 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Jan 18, 2024 | TE: | AB | RLD: | No |
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