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Generated: January 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 070218

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NDA 070218 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Actavis Elizabeth, Inwood Labs, Mylan, Nortec Dev Assoc, Rp Scherer, Upsher-smith Labs, Zydus Pharms Usa Inc, Athenex Inc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Hikma Farmaceutica, Sandoz Inc, Smith And Nephew, Solopak, Morton Grove, West-ward Pharms Int, Anda Repository, Ani Pharms Inc, Dava Pharms Inc, Duramed Pharms Barr, Impax Labs Inc, 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, and Watson Labs Teva, and is included in one hundred and forty-nine NDAs. It is available from fifty suppliers. Additional details are available on the PROPRANOLOL HYDROCHLORIDE profile page.

The generic ingredient in PROPRANOLOL HYDROCHLORIDE is hydrochlorothiazide; propranolol hydrochloride. There are thirty-one 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 070218
Tradename:PROPRANOLOL HYDROCHLORIDE
Applicant:Vintage Pharms
Ingredient:propranolol hydrochloride
Patents:0
Therapeutic Class:Antimigraine Agents
Cardiovascular Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 070218
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 070218
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070218 ANDA Par Pharmaceutical 0603-5483 0603-5483-32 1000 TABLET in 1 BOTTLE (0603-5483-32)
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070218 ANDA Par Pharmaceutical 0603-5483 0603-5483-21 100 TABLET in 1 BOTTLE (0603-5483-21)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength20MG
Approval Date:Aug 1, 1986TE:ABRLD:No

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