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Last Updated: March 19, 2026

Details for New Drug Application (NDA): 216663

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NDA 216663 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Amta, Anda Repository, Extrovis, Inwood Labs, Lupin Ltd, Upsher Smith Labs, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Chartwell Injectable, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Pai Holdings Pharm, Aiping Pharm Inc, Ani Pharms, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Mankind Pharma, Mylan, Northstar Hlthcare, Ph Health, Purepac Pharm, Roxane, Sandoz, Schering, Superpharm, Teva, Warner Chilcott, Watson Labs, Watson Labs Teva, and Rising, and is included in one hundred and thirty-nine NDAs. It is available from thirty-eight suppliers. Additional details are available on the PROPRANOLOL HYDROCHLORIDE profile page.

The generic ingredient in PROPRANOLOL HYDROCHLORIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-two drug master file entries for this compound. Additional details are available on the hydrochlorothiazide; propranolol hydrochloride profile page.

Summary for 216663

Tradename:	PROPRANOLOL HYDROCHLORIDE
Applicant:	Mankind Pharma
Ingredient:	propranolol hydrochloride
Patents:	0

Pharmacology for NDA: 216663

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 216663

Adrenergic beta-Antagonists
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents

Suppliers and Packaging for NDA: 216663

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	216663	ANDA	Lifestar Pharma LLC	70756-094	70756-094-11	100 TABLET in 1 BOTTLE (70756-094-11)
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	216663	ANDA	Lifestar Pharma LLC	70756-094	70756-094-12	1000 TABLET in 1 BOTTLE (70756-094-12)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jan 27, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jan 27, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jan 27, 2026	TE:	AB	RLD:	No

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