Details for New Drug Application (NDA): 075474
✉ Email this page to a colleague
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 075474
Tradename: | BISOPROLOL FUMARATE |
Applicant: | United Res Labs |
Ingredient: | bisoprolol fumarate |
Patents: | 0 |
Formulation / Manufacturing: | see details |
Pharmacology for NDA: 075474
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 075474
Suppliers and Packaging for NDA: 075474
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 075474 | ANDA | TruPharma, LLC | 52817-270 | 52817-270-10 | 100 TABLET, FILM COATED in 1 BOTTLE (52817-270-10) |
BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 075474 | ANDA | TruPharma, LLC | 52817-270 | 52817-270-30 | 30 TABLET, FILM COATED in 1 BOTTLE (52817-270-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
Approval Date: | Oct 25, 2002 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
Approval Date: | Oct 25, 2002 | TE: | AB | RLD: | No |
Complete Access Available with Subscription