Details for New Drug Application (NDA): 203828
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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 203828
Tradename: | NEBIVOLOL HYDROCHLORIDE |
Applicant: | Indchemie Health |
Ingredient: | nebivolol hydrochloride |
Patents: | 0 |
Pharmacology for NDA: 203828
Mechanism of Action | Adrenergic beta-Antagonists |
Medical Subject Heading (MeSH) Categories for 203828
Suppliers and Packaging for NDA: 203828
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203828 | ANDA | A-S Medication Solutions | 50090-5708 | 50090-5708-0 | 5 TABLET in 1 BOTTLE (50090-5708-0) |
NEBIVOLOL HYDROCHLORIDE | nebivolol hydrochloride | TABLET;ORAL | 203828 | ANDA | A-S Medication Solutions | 50090-5708 | 50090-5708-1 | 90 TABLET in 1 BOTTLE (50090-5708-1) |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 2.5MG BASE | ||||
Approval Date: | Jul 29, 2015 | TE: | AB | RLD: | No |
Profile for product number 002
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 5MG BASE | ||||
Approval Date: | Jul 29, 2015 | TE: | AB | RLD: | No |
Profile for product number 003
Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 10MG BASE | ||||
Approval Date: | Jul 29, 2015 | TE: | AB | RLD: | No |
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