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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 203828


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NDA 203828 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Aurobindo Pharma Ltd, Beximco Pharms Usa, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Mankind Pharma, Prinston Inc, Reyoung, Torrent, Unichem, and Watson Labs Inc, and is included in fifteen NDAs. It is available from eighteen suppliers. 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. Nineteen 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 ActionAdrenergic 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:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Jul 29, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Jul 29, 2015TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Jul 29, 2015TE:ABRLD:No

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