Details for New Drug Application (NDA): 203821
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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 203821
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Glenmark Pharms Ltd |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203821
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 203821
Suppliers and Packaging for NDA: 203821
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203821 | ANDA | AvKARE | 42291-871 | 42291-871-30 | 30 TABLET in 1 BOTTLE (42291-871-30) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203821 | ANDA | AvKARE | 42291-872 | 42291-872-90 | 90 TABLET in 1 BOTTLE (42291-872-90) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | May 25, 2017 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | May 25, 2017 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | May 25, 2017 | TE: | AB | RLD: | No |
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