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Details for New Drug Application (NDA): 070309

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NDA 070309 describes PROPRANOLOL HYDROCHLORIDE, which is a drug marketed by Inwood Labs, Sandoz, Rp Scherer, Frontida Biopharm, Duramed Pharms Barr, Upsher Smith, Mylan, Northstar Hlthcare, Purepac Pharm, Superpharm, Roxane, Lederle, Vintage Pharms, Baxter Hlthcare Corp, Schering, Zydus Pharms Usa Inc, Dava Pharms Inc, Fresenius Kabi Usa, Teva, Smith And Nephew, Solopak, Warner Chilcott, Watson Labs, Ipca Labs Ltd, Hikma Farmaceutica, Ivax Sub Teva Pharms, Nortec Dev Assoc, Interpharm, Impax Labs Inc, Ani Pharms Inc, Morton Grove, Par Pharm, Amphastar Pharms Inc, and Actavis Elizabeth, and is included in one hundred and forty-nine NDAs. It is available from forty-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-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 NDA: 070309

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrength60MG
Approval Date:Oct 1, 1986TE:RLD:No

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