Details for New Drug Application (NDA): 216172
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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 216172
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Mankind Pharma |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 216172
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 216172
Suppliers and Packaging for NDA: 216172
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216172 | ANDA | Lifestar Pharma LLC | 70756-025 | 70756-025-30 | 30 TABLET in 1 BOTTLE (70756-025-30) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 216172 | ANDA | Lifestar Pharma LLC | 70756-291 | 70756-291-30 | 30 TABLET in 1 BOTTLE (70756-291-30) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Nov 14, 2022 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Nov 14, 2022 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Nov 14, 2022 | TE: | AB | RLD: | No |
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