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Generated: July 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 075849

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NDA 075849 describes OXAPROZIN, which is a drug marketed by Actavis Elizabeth, Amneal Pharms Co, Apotex Inc, Dr Reddys Labs Ltd, Ivax Sub Teva Pharms, Mylan, Mylan Pharms Inc, Sandoz, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in thirteen NDAs. It is available from twenty suppliers. Additional details are available on the OXAPROZIN profile page.

The generic ingredient in OXAPROZIN is oxaprozin. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the oxaprozin profile page.
Summary for 075849
Tradename:OXAPROZIN
Applicant:Teva
Ingredient:oxaprozin
Patents:0
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 075849
Suppliers and Packaging for NDA: 075849
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
OXAPROZIN oxaprozin TABLET;ORAL 075849 ANDA Teva Pharmaceuticals USA Inc 0093-0924 N 0093-0924-01
OXAPROZIN oxaprozin TABLET;ORAL 075849 ANDA Teva Pharmaceuticals USA Inc 0093-0924 N 0093-0924-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength600MG
Approval Date:Jul 3, 2002TE:ABRLD:No

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