Details for New Drug Application (NDA): 213349
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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 213349
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Ajanta Pharma Ltd |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 213349
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 213349
Suppliers and Packaging for NDA: 213349
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 213349 | ANDA | Ajanta Pharma USA Inc. | 27241-179 | 27241-179-30 | 30 TABLET in 1 BOTTLE (27241-179-30) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 213349 | ANDA | Ajanta Pharma USA Inc. | 27241-180 | 27241-180-30 | 30 TABLET in 1 BOTTLE (27241-180-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Mar 31, 2022 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Mar 31, 2022 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Mar 31, 2022 | TE: | RLD: | No |
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