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Johnson and Johnson
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Generated: May 28, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 074431

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NDA 074431 describes FLURBIPROFEN, which is a drug marketed by Aurolife Pharma Llc, Ivax Sub Teva Pharms, Mylan, Pliva, Sun Pharm Inds Inc, Teva, Theragen, and Bausch And Lomb, and is included in nine NDAs. It is available from seven suppliers. Additional details are available on the FLURBIPROFEN profile page.

The generic ingredient in FLURBIPROFEN is flurbiprofen sodium. There are eleven drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the flurbiprofen sodium profile page.
Summary for 074431
Therapeutic Class:Analgesics
Anti-inflammatory Agents
Formulation / Manufacturing:see details
Pharmacology for NDA: 074431
Medical Subject Heading (MeSH) Categories for 074431
Suppliers and Packaging for NDA: 074431
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
FLURBIPROFEN flurbiprofen TABLET;ORAL 074431 ANDA Teva Pharmaceuticals USA, Inc. 0093-0711 N 0093-0711-01
FLURBIPROFEN flurbiprofen TABLET;ORAL 074431 ANDA Teva Pharmaceuticals USA, Inc. 0093-0711 N 0093-0711-05

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength100MG
Approval Date:May 31, 1995TE:ABRLD:No

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