Details for New Drug Application (NDA): 021742
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NDA 021742 describes BYSTOLIC, which is a drug marketed by Allergan and is included in one NDA. It is available from one supplier. Additional details are available on the BYSTOLIC profile page.
The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-six suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
The generic ingredient in BYSTOLIC is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty-six 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 | 5,759,580 | ⤷ Get Started Free |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-002 | Dec 17, 2007 | 5,759,580 | ⤷ Get Started Free |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-005 | Oct 8, 2008 | 6,545,040 | ⤷ Get Started Free |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | 6,545,040 | ⤷ Get Started Free |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | 6,545,040 | ⤷ Get Started Free |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-004 | Dec 17, 2007 | 5,759,580 | ⤷ Get Started Free |
| Allergan | BYSTOLIC | nebivolol hydrochloride | TABLET;ORAL | 021742-003 | Dec 17, 2007 | 5,759,580 | ⤷ Get Started Free |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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