FDAnews
www.fdanews.com/articles/83286-caraco-receives-final-approval-to-market-generic-ultracet

CARACO RECEIVES FINAL APPROVAL TO MARKET GENERIC ULTRACET

December 20, 2005

Caraco Pharmaceutical Laboratories has received final FDA approval for its abbreviated new drug application for tramadol HCl with acetaminophen in tablet form. Caraco's product is the generic equivalent of Ortho McNeil Pharmaceutical's Ultracet, which is indicated for the short-term management of acute pain.