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Last Updated: August 10, 2020

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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, Mylan, Nortec Dev Assoc, Upsher Smith Labs, Zydus Pharms Usa Inc, Athenex Inc, Baxter Hlthcare Corp, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, Smith And Nephew, Solopak, Hikma, Morton Grove, Ani Pharms Inc, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, Innogenix, Interpharm, Ipca Labs Ltd, Ivax Sub Teva Pharms, Lederle, Northstar Hlthcare, Par Pharm, Purepac Pharm, Roxane, Sandoz, Schering, Superpharm, Teva, Vintage Pharms, Warner Chilcott, Watson Labs, Watson Labs Teva, and Yaopharma Co Ltd, and is included in one hundred and forty NDAs. It is available from thirty-six 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. One supplier is listed 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 Cadila Healthcare 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 Cadila Healthcare 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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