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Last Updated: December 11, 2025

Details for New Drug Application (NDA): 078955

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NDA 078955 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, 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-eight 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 078955

Tradename:	PROPRANOLOL HYDROCHLORIDE
Applicant:	Ipca Labs Ltd
Ingredient:	propranolol hydrochloride
Patents:	0

Pharmacology for NDA: 078955

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 078955

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

Suppliers and Packaging for NDA: 078955

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	078955	ANDA	A-S Medication Solutions	50090-7593	50090-7593-1	100 TABLET in 1 BOTTLE (50090-7593-1)
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	TABLET;ORAL	078955	ANDA	A-S Medication Solutions	50090-7593	50090-7593-5	90 TABLET in 1 BOTTLE (50090-7593-5)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Jun 2, 2008	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	20MG
Approval Date:	Jun 2, 2008	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	40MG
Approval Date:	Jun 2, 2008	TE:	AB	RLD:	No

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