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Last Updated: March 28, 2024

Details for New Drug Application (NDA): 078703


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NDA 078703 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 078703
Tradename:PROPRANOLOL HYDROCHLORIDE
Applicant:Adare Pharms Inc
Ingredient:propranolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 078703
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 078703
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078703 ANDA AvKARE 42291-522 42291-522-01 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-01)
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 078703 ANDA AvKARE 42291-522 42291-522-10 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (42291-522-10)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength60MG
Approval Date:Jul 15, 2011TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength80MG
Approval Date:Jul 15, 2011TE:ABRLD:No

Profile for product number 003

Active Rx/OTC/Discontinued:RXDosage:CAPSULE, EXTENDED RELEASE;ORALStrength120MG
Approval Date:Jul 15, 2011TE:ABRLD:No

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