Details for New Drug Application (NDA): 075643
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NDA 075643 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 075643
| Tradename: | BISOPROLOL FUMARATE |
| Applicant: | Rubicon Research |
| Ingredient: | bisoprolol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 075643
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 075643
Suppliers and Packaging for NDA: 075643
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 075643 | ANDA | TruPharma LLC | 52817-268 | 52817-268-30 | 30 TABLET, FILM COATED in 1 BOTTLE (52817-268-30) |
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 075643 | ANDA | Bryant Ranch Prepack | 71335-9755 | 71335-9755-1 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-9755-1) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Nov 16, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Nov 16, 2000 | TE: | AB | RLD: | No | ||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 2.5MG | ||||
| Approval Date: | Mar 7, 2025 | TE: | RLD: | No | |||||
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