Last Updated: November 8, 2026

Details for New Drug Application (NDA): 219460

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NDA 219460 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Amta, Anda Repository, Chartwell Rx, Creekwood Pharms, Inwood Labs, Ipca Labs Ltd, Lupin, Micro Labs, Upsher Smith Labs, Zydus Pharms Usa Inc, Baxter Hlthcare Corp, Chartwell Injectable, Fresenius Kabi Usa, Hikma Farmaceutica, Sciegen Pharms, Smith And Nephew, Solopak, Hikma, Pai Holdings, Pai Holdings Pharm, Aiping Pharm Inc, Ani Pharms, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, 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 forty-two NDAs. It is available from forty suppliers. Additional details are available on the PROPRANOLOL HYDROCHLORIDE profile page.

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

Summary for 219460

Tradename:	PROPRANOLOL HYDROCHLORIDE
Applicant:	Creekwood Pharms
Ingredient:	propranolol hydrochloride
Patents:	0

Pharmacology for NDA: 219460

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 219460

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

Suppliers and Packaging for NDA: 219460

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	219460	ANDA	Creekwood Pharmaceuticals LLC	82619-132	82619-132-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82619-132-01)
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	219460	ANDA	Creekwood Pharmaceuticals LLC	82619-132	82619-132-02	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (82619-132-02)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Aug 14, 2026	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	80MG
Approval Date:	Aug 14, 2026	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Aug 14, 2026	TE:	AB	RLD:	No

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