Details for New Drug Application (NDA): 078635
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NDA 078635 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 078635
| Tradename: | BISOPROLOL FUMARATE |
| Applicant: | Unichem |
| Ingredient: | bisoprolol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 078635
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 078635
Suppliers and Packaging for NDA: 078635
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 078635 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-126 | 29300-126-01 | 100 TABLET in 1 BOTTLE, PLASTIC (29300-126-01) |
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 078635 | ANDA | Unichem Pharmaceuticals (USA), Inc. | 29300-126 | 29300-126-05 | 500 TABLET in 1 BOTTLE, PLASTIC (29300-126-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Aug 18, 2009 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Aug 18, 2009 | TE: | AB | RLD: | No | ||||
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