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Last Updated: March 29, 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, Mylan, Nortec Dev Assoc, 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, Ani Pharms, Chartwell Rx, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Purepac Pharm, Roxane, Sandoz, Schering, Strides Pharma, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Rising, and is included in one hundred and thirty-eight NDAs. It is available from thirty-seven 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
Formulation / Manufacturing:see details
Pharmacology for NDA: 090321
Mechanism of ActionAdrenergic beta-Antagonists
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:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Mar 25, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength80MG
Approval Date:Mar 25, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Mar 25, 2011TE:ABRLD:No

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