Details for New Drug Application (NDA): 204891
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NDA 204891 describes BISOPROLOL FUMARATE, which is a drug marketed by Alembic, Aurobindo Pharma, Dash Pharms Natco, Harman Finochem, Novitium Pharma, Prinston Inc, Rubicon, Teva Pharms, Unichem, United Res Labs, 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-four NDAs. It is available from twenty-one 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. Thirteen 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. Thirteen suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 204891
| Tradename: | BISOPROLOL FUMARATE |
| Applicant: | Alembic |
| Ingredient: | bisoprolol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 204891
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 204891
Suppliers and Packaging for NDA: 204891
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 204891 | ANDA | Alembic Pharmaceuticals Limited | 46708-603 | 46708-603-30 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-30) |
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 204891 | ANDA | Alembic Pharmaceuticals Limited | 46708-603 | 46708-603-31 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (46708-603-31) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Jan 11, 2017 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Jan 11, 2017 | TE: | AB | RLD: | No | ||||
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