Details for New Drug Application (NDA): 212682
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The generic ingredient in NEBIVOLOL HYDROCHLORIDE 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 212682
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Prinston Inc |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 212682
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 212682
Suppliers and Packaging for NDA: 212682
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 212682 | ANDA | Solco Healthcare US, LLC | 43547-524 | 43547-524-03 | 30 TABLET in 1 BOTTLE (43547-524-03) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 212682 | ANDA | Solco Healthcare US, LLC | 43547-524 | 43547-524-09 | 90 TABLET in 1 BOTTLE (43547-524-09) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Apr 7, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Apr 7, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Apr 7, 2022 | TE: | AB | RLD: | No |
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