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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 203825


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NDA 203825 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Ajanta Pharma Ltd, Alkem Labs Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Beximco Pharms Usa, Cadila Pharms Ltd, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Mankind Pharma, MSN, Prinston Inc, Reyoung, Torrent, Unichem, and Watson Labs Inc, and is included in seventeen NDAs. It is available from twenty-two 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. Twenty-three suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.
Summary for 203825
Tradename:NEBIVOLOL HYDROCHLORIDE
Applicant:Hetero Labs Ltd Iii
Ingredient:nebivolol hydrochloride
Patents:0
Pharmacology for NDA: 203825
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 203825
Suppliers and Packaging for NDA: 203825
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203825 ANDA Camber Pharmaceuticals, Inc. 31722-585 31722-585-01 100 TABLET in 1 BOTTLE (31722-585-01)
NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203825 ANDA Camber Pharmaceuticals, Inc. 31722-585 31722-585-30 30 TABLET in 1 BOTTLE (31722-585-30)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Nov 3, 2020TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Nov 3, 2020TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Nov 3, 2020TE:ABRLD:No

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