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Details for New Drug Application (NDA): 203659

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NDA 203659 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Indchemie Health, Alkem Labs Ltd, Amerigen Pharms Ltd, and Watson Labs Inc, and is included in four 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 thirteen 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 NDA: 203659

Tradename:
NEBIVOLOL HYDROCHLORIDE
Applicant:
Amerigen Pharms Ltd
Ingredient:
nebivolol hydrochloride
Patents:0

Pharmacology for NDA: 203659

Mechanism of ActionAdrenergic beta-Antagonists

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 43975-248-03 30 TABLET in 1 BOTTLE (43975-248-03)
NEBIVOLOL HYDROCHLORIDE
nebivolol hydrochloride
TABLET;ORAL 203659 ANDA Amerigen Pharmaceuticals Inc. 43975-248 43975-248-10 100 TABLET in 1 BOTTLE (43975-248-10)

Summary for product number 001

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

Summary for product number 002

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

Summary for product number 003

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


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