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Generated: May 27, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203659

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NDA 203659 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Amerigen Pharms Ltd, Glenmark Pharms Ltd, Indchemie Health, Torrent Pharms Ltd, and Watson Labs Inc, and is included in six NDAs. It is available from one supplier. Additional details are available on the NEBIVOLOL HYDROCHLORIDE profile page.

The generic ingredient in NEBIVOLOL HYDROCHLORIDE is nebivolol hydrochloride. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 203659
Tradename:NEBIVOLOL HYDROCHLORIDE
Applicant:Amerigen Pharms Ltd
Ingredient:nebivolol hydrochloride
Patents:0
Pharmacology for NDA: 203659
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 203659
Suppliers and Packaging for NDA: 203659
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203659 ANDA Amerigen Pharmaceuticals Inc. 43975-248 N 43975-248-03
NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203659 ANDA Amerigen Pharmaceuticals Inc. 43975-248 N 43975-248-10

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Apr 16, 2015TE:RLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Apr 16, 2015TE:RLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Apr 16, 2015TE:RLD:No

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