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U.S. Department of Health and Human Services

Drugs

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Approvals - May 2006

 ANDA NumberGeneric Drug NameApplicantApproval Date
165-219NEOMYCIN & POLYMYXIN B SULFATES & HYDROCORTISONE OTIC SUSPENSION, 3.5 MG (BASE)/10,000 U,1%/MLPHARMAFORCE, INC.5/1/2006 
265-274CEFTRIAXONE FOR INJECTION USP, 10 G/VIAL (PHARMACY BULK PACKAGE)TEVA PHARMACEUTICALS USA5/1/2006 
377-277COLESTIPOL HYDROCHLORIDE FOR ORAL SUSPENSION USP, 5 G PACKET OR SCOOPFULIMPAX LABORATORIES, INC.5/2/2006 
477-445POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 G PACKET OR SCOOPFULTEVA PHARMACEUTICALS USA5/4/2006 
577-354KETOTIFEN FUMARATE OPHTHALMIC SOLUTION, 0.025%APOTEX, INC.5/9/2006 
677-754LORAZEPAM TABLETS USP, 0.5 MG, 1 MG, AND 2 MGVINTAGE PHARMACEUTICALS, LLC5/10/2006 
765-180CEFTRIAXONE FOR INJECTION USP, 1 GRAM/VIALWOCKHARDT LIMITED5/12/2006 
840-679OXYCODONE AND ACETAMINOPHEN TABLETS USP, 2.5 MG/400 MGMIKART INC.5/16/2006 
965-264CEFDINIR CAPSULES, 300 MGLUPIN LIMITED5/19/2006 
1076-765ESCITALOPRAM OXALATE TABLETS, 5 MG, 10 MG, AND 20 MGIVAX PHARMACEUTICALS, INC.5/22/2006 
1177-447MOMETASONE FUROATE CREAM USP, 0.1%G&W LABORATORIES, INC.5/22/2006 
1240-484ORPHENADRINE CITRATE INJECTION USP, 30 MG/ML; 2 ML VIALSAKORN INC.5/24/2006 
1377-197METRONIDAZOLE TOPICAL LOTION, 0.75%ALTANA INC.5/24/2006 
1477-893POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFULCOASTAL PHARMACEUTICALS, INC.5/24/2006 
1577-736POLYETHYLENE GLYCOL 3350 NF POWDER FOR ORAL SOLUTION, 17 GRAMS/SCOOPFULKALI LABORATORIES, INC.5/26/2006 
1640-644CYPROHEPTADINE HYDROCHLORIDE TABLETS USP, 4 MGSTASON PHARMACEUTICALS, INC.5/30/2006 
1740-663WARFARIN SODIUM TABLETS USP, 1 MG, 2 MG, 2.5 MG, 3 MG, 4 MG, 5 MG, 6 MG, 7.5 MG, AND 10 MGZYDUS PHARMACEUTICALS USA, INC.5/30/2006 
1865-259CEFDINIR FOR ORAL SUSPENSION, 125 MG/5 MLLUPIN PHARMACEUTICALS INC.5/31/2006 
1965-266CLARITHROMYCIN TABLETS USP, 250 MG AND 500 MGWOCKHARDT LIMITED5/31/2006 
2065-315NYSTATIN CREAM USP, 100,000 UNITS/GRAMVINTAGE PHARMACEUTICALS, LLC5/31/2006 
2165-356DOXYCYCLINE TABLETS, 50 MG, 75 MG, AND 100 MGRANBAXY LABORATORIES LIMITED5/31/2006 
2277-681LEVONORGESTREL AND ETHINYL ESTRADIOL TABLETS USP, 0.1 MG/0.02 MG; 28-DAY REGIMENWATSON LABORATORIES, INC.5/31/2006 
2377-869ZONISAMIDE CAPSULES, 25 MG, 50 MG, AND 100 MGINVAGEN PHARMACEUTICALS, INC.5/31/2006