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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 203683

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NDA 203683 describes NEBIVOLOL HYDROCHLORIDE, which is a drug marketed by Alkem Labs Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Rx, Glenmark Pharms Ltd, Hetero Labs Ltd Iii, Indchemie Health, Macleods Pharms Ltd, Mankind Pharma, MSN, Prinston Inc, Regcon Holdings, Reyoung, Torrent, Unichem, and Watson Labs Inc, and is included in eighteen NDAs. It is available from twenty-five 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-six suppliers are listed for this compound. Additional details are available on the nebivolol hydrochloride profile page.

Summary for 203683

Tradename:	NEBIVOLOL HYDROCHLORIDE
Applicant:	Watson Labs Inc
Ingredient:	nebivolol hydrochloride
Patents:	0

Medical Subject Heading (MeSH) Categories for 203683

Adrenergic beta-1 Receptor Agonists
Antihypertensive Agents
Vasodilator Agents

Profile for product number 001

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 2.5MG BASE
Approval Date:	Nov 27, 2015	TE:		RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 5MG BASE
Approval Date:	Nov 27, 2015	TE:		RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	DISCN	Dosage:	TABLET;ORAL			Strength	EQ 10MG BASE
Approval Date:	Nov 27, 2015	TE:		RLD:	No

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