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Last Updated: March 29, 2024

Details for New Drug Application (NDA): 203966


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NDA 203966 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 203966
Tradename:NEBIVOLOL HYDROCHLORIDE
Applicant:Torrent
Ingredient:nebivolol hydrochloride
Patents:0
Pharmacology for NDA: 203966
Mechanism of ActionAdrenergic beta-Antagonists
Medical Subject Heading (MeSH) Categories for 203966
Suppliers and Packaging for NDA: 203966
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203966 ANDA Major Pharmaceuticals 0904-7189 0904-7189-04 30 BLISTER PACK in 1 CARTON (0904-7189-04) / 1 TABLET in 1 BLISTER PACK
NEBIVOLOL HYDROCHLORIDE nebivolol hydrochloride TABLET;ORAL 203966 ANDA Major Pharmaceuticals 0904-7190 0904-7190-04 30 BLISTER PACK in 1 CARTON (0904-7190-04) / 1 TABLET in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 2.5MG BASE
Approval Date:Mar 2, 2018TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 5MG BASE
Approval Date:Mar 2, 2018TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 10MG BASE
Approval Date:Mar 2, 2018TE:ABRLD:No

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