Details for New Drug Application (NDA): 021742
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The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 021742
Tradename: | BYSTOLIC |
Applicant: | Allergan |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 021742
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 021742
Suppliers and Packaging for NDA: 021742
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742 | NDA | Allergan, Inc. | 0456-1402 | 0456-1402-01 | 100 TABLET in 1 BOTTLE (0456-1402-01) |
BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742 | NDA | Allergan, Inc. | 0456-1402 | 0456-1402-30 | 30 TABLET in 1 BOTTLE (0456-1402-30) |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Dec 17, 2007 | TE: | AB | RLD: | Yes |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Dec 17, 2007 | TE: | AB | RLD: | Yes |
Profile for product number 004
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Dec 17, 2007 | TE: | AB | RLD: | Yes |
Expired US Patents for NDA 021742
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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