Details for New Drug Application (NDA): 218303
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NDA 218303 describes BISOPROLOL FUMARATE, which is a drug marketed by Alembic, Aurobindo Pharma, Harman Finochem, Micro Labs, Natco Pharma Usa, Novitium Pharma, Prinston Inc, Rubicon Research, Teva Pharms, Tp Anda Holdings, Unichem, Unique Pharm, Zydus Lifesciences, Actavis Elizabeth, Apothecon, Aurobindo Pharma Ltd, 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-eight NDAs. It is available from twenty-four 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. Twelve 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. Twelve suppliers are listed for this compound. Additional details are available on the bisoprolol fumarate; hydrochlorothiazide profile page.
Summary for 218303
| Tradename: | BISOPROLOL FUMARATE |
| Applicant: | Micro Labs |
| Ingredient: | bisoprolol fumarate |
| Patents: | 0 |
Pharmacology for NDA: 218303
| Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 218303
Suppliers and Packaging for NDA: 218303
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 218303 | ANDA | Micro Labs Limited | 42571-470 | 42571-470-01 | 100 TABLET, FILM COATED in 1 BOTTLE (42571-470-01) |
| BISOPROLOL FUMARATE | bisoprolol fumarate | TABLET;ORAL | 218303 | ANDA | Micro Labs Limited | 42571-470 | 42571-470-05 | 500 TABLET, FILM COATED in 1 BOTTLE (42571-470-05) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 5MG | ||||
| Approval Date: | Mar 9, 2026 | TE: | AB | RLD: | No | ||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 10MG | ||||
| Approval Date: | Mar 9, 2026 | TE: | AB | RLD: | No | ||||
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