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-three 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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