Details for New Drug Application (NDA): 219044
✉ Email this page to a colleague
NDA 219044 describes BISOPROLOL FUMARATE, which is a drug marketed by Alembic, Aurobindo Pharma, Dash Pharms Natco, Harman Finochem, Novitium Pharma, Prinston Inc, Rubicon Research, Teva Pharms, Tp Anda Holdings, Unichem, Unique Pharm, Zydus Lifesciences, Actavis Elizabeth, Apothecon, Cadila, Chartwell Rx, Edenbridge Pharms, Epic Pharma Llc, Glenmark Pharms Ltd, Ivax Sub Teva Pharms, Mylan, Teva, and Watson Labs Teva, and is included in twenty-five NDAs. It is available from twenty-three suppliers. Additional details are available on the BISOPROLOL FUMARATE profile page.
The generic ingredient in BISOPROLOL FUMARATE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
The generic ingredient in BISOPROLOL FUMARATE is bisoprolol fumarate; hydrochlorothiazide. There are twelve drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 219044
| Tradename: | BISOPROLOL FUMARATE |
| Applicant: | Unique Pharm |
| Ingredient: | bisoprolol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 219044
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 219044
Suppliers and Packaging for NDA: 219044
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 219044 | ANDA | Rising Pharma Holdings, Inc. | 64980-709 | 64980-709-01 | 100 TABLET, FILM COATED in 1 BOTTLE (64980-709-01) |
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 219044 | ANDA | Rising Pharma Holdings, Inc. | 64980-709 | 64980-709-03 | 30 TABLET, FILM COATED in 1 BOTTLE (64980-709-03) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Apr 16, 2025 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Apr 16, 2025 | TE: | AB | RLD: | No | ||||
Complete Access Available with Subscription
