Details for New Drug Application (NDA): 208717
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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 208717
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Cadila Pharms Ltd |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 208717
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 208717
Suppliers and Packaging for NDA: 208717
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 208717 | ANDA | Cadila Pharmaceuticals Limited | 71209-058 | 71209-058-01 | 30 TABLET in 1 BOTTLE (71209-058-01) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 208717 | ANDA | Cadila Pharmaceuticals Limited | 71209-058 | 71209-058-04 | 90 TABLET in 1 BOTTLE (71209-058-04) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Dec 17, 2021 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Dec 17, 2021 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Dec 17, 2021 | TE: | AB | RLD: | No |
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