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Last Updated: November 21, 2024

Details for New Drug Application (NDA): 090321

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NDA 090321 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Adare Pharms Inc, Amta, Inwood Labs, Lupin Ltd, Nortec Dev Assoc, Rising, 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, Endo Operations, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Mylan, Northstar Hlthcare, Purepac Pharm, Roxane, Sandoz, Schering, Superpharm, Teva, Warner Chilcott, Watson Labs, and Watson Labs Teva, and is included in one hundred and thirty-eight NDAs. It is available from thirty-nine 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 090321

Tradename:	PROPRANOLOL HYDROCHLORIDE
Applicant:	Zydus Pharms Usa Inc
Ingredient:	propranolol hydrochloride
Patents:	0

Pharmacology for NDA: 090321

Mechanism of Action	Adrenergic beta-Antagonists

Medical Subject Heading (MeSH) Categories for 090321

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

Suppliers and Packaging for NDA: 090321

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090321	ANDA	Zydus Lifesciences Limited	65841-745	65841-745-01	100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-745-01)
PROPRANOLOL HYDROCHLORIDE	propranolol hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	090321	ANDA	Zydus Lifesciences Limited	65841-745	65841-745-05	500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (65841-745-05)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	60MG
Approval Date:	Mar 25, 2011	TE:	AB	RLD:	No

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	80MG
Approval Date:	Mar 25, 2011	TE:	AB	RLD:	No

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE, EXTENDED RELEASE;ORAL			Strength	120MG
Approval Date:	Mar 25, 2011	TE:	AB	RLD:	No

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