Drugs
First-Time Generic Drug Approvals - July 2011
Generic Drug Name Generic Manufacturer Brand Name Approval Date 1 LEVOFLOXACIN AND DEXTROSE (5%) INJECTION, 5 MG/ML; PACKAGED IN 250 MG/50 ML, 500 MG/100 ML AND 750 MG/150 ML SINGLE-USE FLEXIBLE CONTAINERS ACS DOBFAR INFO S.A. LEVAQUIN AND DEXTROSE (5%) INJECTION 7/7/2011 2 FONDAPARINUX SODIUM INJECTION, 2.5 MG/0.5 ML, 5 MG/0.4 MG, 7.5 MG/0.6 ML AND 10 MG/0.8ML PACKAGED IN PREFILLED SINGLE-DOSE SYRINGES DR. REDDY'S LABORATORIES LIMITED ARIXTRA INJECTION 7/11/2011 3 MORPHINE SULFATE ORAL SOLUTION, 100 MG/5 ML (20 MG/ML) MALLINCKRODT INC. MORPHINE SULFATE ORAL SOLUTION 7/15/2011 4 ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG TEVA PHARMACEUTICALS USA UROXATRAL EXTENDED-RELEASE TABLETS 7/18/2011 5 ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG SUN PHARMA GLOBAL FZE UROXATRAL EXTENDED-RELEASE TABLETS 7/18/2011 6 ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG APOTEX INC. UROXATRAL EXTENDED-RELEASE TABLETS 7/18/2011 7 ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG TORRENT PHARMACEUTICALS LIMITED UROXATRAL EXTENDED-RELEASE TABLETS 7/18/2011 8 ALFUZOSIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 10 MG MYLAN PHARMACEUTICALS, INC. UROXATRAL EXTENDED-RELEASE TABLETS 7/18/2011 9 METRONIDAZOLE GEL USP, (TOPICAL) 1% TOLMAR INC. METROGEL 1% 7/22/2011 10 PARICALCITOL INJECTION USP, 2 MCG/ML AND 5 MCG/ML SANDOZ CANADA, INC. ZEMPLAR INJECTION 7/27/2011 11 PHENTERMINE RESIN EXTENDED-RELEASE CAPSULES, 15 MG (BASE) AND 30 MG (BASE) LANNETT HOLDINGS, INC. IONAMIN CAPSULES 7/28/2011







