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Generated: December 11, 2018

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Details for New Drug Application (NDA): 070219

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NDA 070219 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, Fosun Pharma, Fresenius Kabi Usa, Hikma Farmaceutica, 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, Watson Labs Teva, and Yaopharma Co Ltd, and is included in one hundred and forty-three NDAs. It is available from forty-eight 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 070219
Tradename:PROPRANOLOL HYDROCHLORIDE
Applicant:Vintage Pharms
Ingredient:propranolol hydrochloride
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 070219
Mechanism of ActionAdrenergic beta-Antagonists
Suppliers and Packaging for NDA: 070219
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070219 ANDA Par Pharmaceutical 0603-5484 0603-5484-21 100 TABLET in 1 BOTTLE (0603-5484-21)
PROPRANOLOL HYDROCHLORIDE propranolol hydrochloride TABLET;ORAL 070219 ANDA Par Pharmaceutical 0603-5484 0603-5484-32 1000 TABLET in 1 BOTTLE (0603-5484-32)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength40MG
Approval Date:Aug 1, 1986TE:ABRLD:No

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