Details for New Drug Application (NDA): 216568
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The generic ingredient in NEBIVOLOL HYDROCHLORIDE is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Twenty suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 216568
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Beximco Pharms Usa |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216568
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 216568
Suppliers and Packaging for NDA: 216568
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216568 | ANDA | Apnar Pharma LP | 24689-159 | 24689-159-01 | 30 TABLET in 1 BOTTLE (24689-159-01) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216568 | ANDA | Apnar Pharma LP | 24689-160 | 24689-160-01 | 30 TABLET in 1 BOTTLE (24689-160-01) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 30, 2023 | TE: | AB | RLD: | No |
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