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. Nineteen 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 | Glenmark Pharmaceuticals Inc., USA | 68462-615 | 68462-615-01 | 100 TABLET in 1 BOTTLE (68462-615-01) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203821 | ANDA | Glenmark Pharmaceuticals Inc., USA | 68462-615 | 68462-615-11 | 10 BLISTER PACK in 1 CARTON (68462-615-11) / 10 TABLET in 1 BLISTER PACK |
Profile for product number 001
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | May 25, 2017 | TE: | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | May 25, 2017 | TE: | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | DISCN | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | May 25, 2017 | TE: | RLD: | No |
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